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  • A 5-year Longitudinal Observational Study of the Natural History and Management of Patients with Hepatocellular Carcinoma - NCT02954094

    Primary Aims 1. Establish a longitudinal observational cohort to understand the natural history and management of HCC, including the safety and outcomes of HCC treatment interventions utilized in usual clinical practice Secondary Aims 1. Evaluate the impact of HCC treatment interventions and concomitant medications on comorbid conditions and liver function 2. Evaluate patient-reported outcomes measures during the natural course of HCC and management with HRQoL questionnaires 3. Establish a Biorepository Specimen Bank (BSB) Exploratory Aims 1. Investigate optimal type, duration, and sequence/combination of treatment interventions for HCC used in usual clinical practice 2. Perform biomarker analyses to identify potential markers predictive of response patterns or side effect profiles 3. Generate hypotheses that may lead to further investigations regarding natural course and treatment of HCC

    View All Details
    • Protocol Number:
      001720

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Liver

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Male or female patients, age ≥18 years 2. Patients with a histological/cytological or radiological diagnosis of HCC (mixed HCC cholangiocarcinoma may be included; patients who are candidates for surgical and non-surgical treatment, as well as those being followed without specific HCC therapy may be included)

    Exclusion Criteria:

      1. Inability to provide written informed consent

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Robert Wood Johnson University Hospital
    • Rutgers Cancer Institute
  • A bilingual virtually-based intervention (PEDALL) for the prevention of weight gain in childhood ALL patients considering key genetic and sociodemographic risk factors - NCT05963971

    Primary Objective To prevent the development of overweight and obesity (OW/OB) during maintenance chemotherapy using a six-month virtually delivered dietary education intervention (PEDALL) in English and Spanish speaking families of children and adolescents undergoing treatment for ALL. Exploratory Objectives 1. To assess the effect of intervention on BMI z-score trajectories over time (from time zero to one-year post-completion of treatment for ALL) and modification of this effect by genetic and sociodemographic factors. 2. To examine the modifying effect of genetic predisposition to OW/OB, defined by a genome-wide polygenic score (GPS) for obesity optimized for Hispanic and Non-Hispanic application, on the efficacy of PEDALL for the prevention of OW/OB in children and adolescents undergoing treatment for ALL. 3. To examine the modifying effect of multi-level sociodemographic factors on the efficacy of PEDALL for the prevention of OW/OB in children and adolescents undergoing treatment for ALL. 4. To understand the effect of intervention on reported lifestyle behaviors as measured by World Cancer Research Foundation/American Institute for Cancer Research lifestyle guidelines. 5. To understand contextual factors that shaped the recruitment and retainment of participants and to identify strategies that may hinder or support implementation within routine care at their site including resource, training and technological needs using a one-time, brief structured survey at the end of the study with study site designate. 6. To understand individual factors and site-specific factors that shaped both experience with and response to the intervention using a one-time, brief open-ended questionnaire to patients and caregivers.

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    • Protocol Number:
      112307

    • Principal Investigator:
      Peter D. Cole

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Age: 5-21 years old at enrollment
    • Diagnosis and Treatment: Plan to receive or are receiving maintenance or continuation chemotherapy for B- or T-cell ALL, or mixed phenotype acute leukemia.
    • Timing: Patient is eligible for entry only if it is feasible to start the study intervention during the first month of the maintenance phase of ALL therapy.
    • Language: Fluency in English or Spanish
    • Weight Status: Healthy weight at baseline as determined by BMI z-score < 1.04 and >-1.04 for those under 5-18, and BMI between 19 and 25 for those >18.
    • Ethnicity: Hispanic or Non-Hispanic of any race.

    Exclusion Criteria:

    • Patients on nutrition support (enteral or parenteral nutrition)
    • Patients with a history of eating disorder

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute
  • A Digital Intervention to Improve Skin Self-Examination Among Melanoma Survivors. - NCT05373823

    Aim 1. To enhance MSS by collaborating with multi-level stakeholders. We will collaborate with stakeholders in enhancing MSS through qualitative interviews and usability testing of potential enhancements. Enhancements are based on empirically validated behavior change techniques (BCTs) and our prior study. We will utilize an iterative process that includes: (1) key informant interviews with survivors, providers, and professional organizations regarding proposed enhancements; (2) conversion to an enhanced mobile-based delivery platform; (3) usability testing, and; (4) iterative program refinements. Aim 2. To evaluate the effects of enhanced MSS on thorough SSE in an RCT and examine its impact on the diagnosis of new/recurrent melanomas (N= 300). We will conduct a RCT comparing MSS and a non-interactive educational webpage with 300 survivors to test its effects on SSE. We propose that MSS participants will be more likely to perform thorough SSE over the 18-month follow-up. We will explore the impact of MSS on new/recurrent melanomas. We propose that there will be more earlier stage melanomas diagnosed in MSS as compared with UC. Aim 3. To assess selected implementation outcomes and identify factors relevant to future scale-up for widespread dissemination and implementation. We will use mixed methods to assess implementation outcomes and explore perspectives from survivors, care providers, and professional organizations about how to best disseminate and implement MSS on a broad scale. The sub-aims are: 3a) To estimate program costs and assess cost-effectiveness of MSS relative to control. We hypothesize that MSS costs will be higher than UC. We expect that MSS will be a more cost-effective strategy, given its greater effectiveness to increase SSE and identify new or recurrent melanoma. If our findings support this as expected, exploratory cost-effectiveness analyses from the health care and societal perspectives will be conducted using simulation models of melanoma-related costs, disease progression, and survival over 5- and 10-year analysis horizons. 3b) To examine MSS reach, adoption, engagement, acceptability, appropriateness, feasibility, and maintenance. For reach, we predict that demographic variables will not differ from the general population of melanoma survivors. For adoption, we propose that the proportion of contacted/eligible survivors randomized to MSS who consent, complete the baseline, and log into MSS will be equal or greater than the efficacy trial. For engagement, we propose that 80% of MSS participants will log in. For acceptability, we predict MSS will be rated as highly acceptable. 3c) To identify and describe contextual factors from multilevel stakeholders as key to scale-up and widespread implementation of MSS, including consideration of potential delivery settings, timing of delivery, and needed resources to promote its implementation and sustainability.

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    • Protocol Number:
      132202

    • Principal Investigator:
      Sharon Manne

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Melanoma, Skin

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Diagnosis of primary pathologic stage 0-III cutaneous malignant melanoma
    • Three months to five years post-surgery
    • No current evidence of cancer
    • Not adherent to thorough SSE (i.e., did not check entire body at least once during the past three months)
    • ≥ 18 years old
    • Internet access
    • Able to speak/read English
    • Able to provide informed consent

    Exclusion Criteria:

    • Children

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute
  • A digital skin cancer prevention intervention for adolescents and their parents - NCT07681791

    Aim 1. Refine and finalize procedures and a library of sun safety and general health MMS (teen) and Facebook (parent) messages, employing user-centered design with teens and parents to ensure acceptability and engagement. Aim 2. Conduct a single arm pilot test of SST Teen + SST Parent with 52 dyads to determine: a) feasibility of enrolling socio-demographically diverse parent-teen dyads b) engagement with/acceptability of the MMS intervention via message views and acceptability ratings c) outcome data collection feasibility (i.e., daily diary, UVR exposure measured by UVR dosimeter) d) retention rates for teens and parents at 3 and 6 months for planning study design.

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    • Protocol Number:
      132501

    • Principal Investigator:
      Carolyn J Heckman

    • Phase:
      N/A

    • Scope:
      Local

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      Parents and teens are participating as dyads, meaning both the parent and the teen needto be deemed eligible based on the criteria below to be able to participate.Teens
    • Must be ages 13-17 years
    • Live with study parent equal to or greater than half time in US
    • Have experienced sunburn or indoor tanned in the last year or have a suboptimal sun protection score
    • Have no personal history of melanoma or severe medical condition that prevents participation
    • Have access to smartphone
    • Speak and read EnglishParents/Guardians
    • Must be age 18 or older
    • Live with a teen equal to or greater than half time in US
    • Have a teen who had experienced sunburn or indoor tanned in the last year or have a suboptimal sun protection score
    • Have no personal history of melanoma or severe medical condition that prevents participation
    • Have internet at home, a Facebook account, and be willing to use Facebook daily
    • Have access to smartphone
    • Speak and read English

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

  • A Dose Escalation and Expansion Study of XB371 Administered in Participants with Locally Advanced or Metastatic Solid Tumors - NCT07123103

    Primary: To characterize the safety and tolerability of XB371 Secondary: To characterize the PK of XB371, total antibody (unconjugated and conjugated), and unconjugated payload (belotecan) To characterize the immunogenicity of XB371 To determine the RDE of XB37a To characterize the preliminary antitumor activity of XB371b

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    • Protocol Number:
      052504

    • Principal Investigator:
      Sanjay Goel

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      XB371

    Read Inclusion & Exclusion Criteria

    Key Inclusion Criteria:

    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
    • Minimum life expectancy of ≥ 12 weeks.
    • Recurrent locally advanced or metastatic solid tumors.
    • Adequate end organ and bone marrow function.

    Key Exclusion Criteria:

    • Primary brain tumors or known active brain metastases, leptomeningeal, or cranial epidural disease.
    • History of interstitial lung disease (ILD) of any grade or history of organizing pneumonia.
    • Has acute ocular infection, acute or chronic ulcerative/cicatricial condition of conjunctiva or cornea.
    • Known history of immunodeficiency virus (HIV) unless specific criteria are met.
    • Active infection with hepatitis C virus (HCV) defined as positive for HCV antibody.
    • Major surgery within 4 weeks before the first dose of study treatment.
    • Received radiation therapy within 2 weeks before the first dose of study treatment.
    • Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study treatment.NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

  • A Feasibility Study of E7 TCR-T Cell Induction Therapy for Locoregionally Advanced HPV-Associated Cancers. - NCT05639972

    Primary Objective: - To determine the feasibility of administering E7 TCR-T cell therapy as induction treatment for LAHPVC Secondary Objectives: - To determine the objective tumor response rate at 6-weeks after treatment - To assess 2-year and 5-year disease free survival (DFS) - To collect biospecimens for exploratory translational research

    View All Details
    • Protocol Number:
      192104

    • Principal Investigator:
      Christian Hinrichs

    • Phase:
      Phase I

    • Scope:
      Local

    • Applicable Disease Sites:
      Breast ,Cervix ,Lip, Oral Cavity and Pharynx ,Other Female Genital ,Other Male Genital ,Stomach

    • Therapies Involved:
      Immunotherapy

    • Drugs Involved:
      TCR-T Cell infusion

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria: Subjects must meet all the following criteria to participate in this

      study. 1. Histologically confirmed carcinoma of a primary tumor site and stage indicated in Table 3 of the protocol. 2. Tumor with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory. 3. HLA-A*02:01 allele determined by testing performed in a CLIA certified laboratory. Participants may be enrolled based on low resolution typing (i.e., HLA-A*02) but the HLA-A*02:01 allele type must be confirmed prior to apheresis. 4. Measurable disease per RECIST Criteria Version 1.1 or PERCIST. 5. Age ≥ 18 years. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening. 7. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy test is not required for women who have had a bilateral oophorectomy or hysterectomy. 8. Men and women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal barrier method of birth control, abstinence, tubal ligation, or vasectomy) prior to study entry and for four months after treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. 9. Seronegative for HIV antibody, hepatitis B surface antigen (HBsAg), and hepatitis C antibody. If a hepatitis C antibody test is positive, then testing for antigen by reverse transcription polymerase chain reaction (RT-PCR) must be negative. 10. Participants must have organ and marrow function as defined below: 1. Leukocytes > 3,000/mcL 2. Absolute neutrophil count > 1,500/mcL 3. Platelets > 100,000/mcL 4. Hemoglobin > 9.0 g/dL 5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin < 3.0 mg/dL. 6. Serum aspartate aminotransferase (AST) (SGOT)/ alanine transaminase (ALT) (SGPT) < 2.5 x upper limit of normal (ULN) 7. Calculated creatinine clearance (CrCl) >50 mL/min/1.73 m2 for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation). 8. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or aPTT within therapeutic range and no history of severe hemorrhage. 11. Participants must be able to understand and be willing to sign the written informed consent document. 12. Participants must agree to participate in Rutgers protocol 192103 (Pro2021002307) for gene therapy long term follow up and in Rutgers protocol 192002 (Pro2021000281) for biospecimen studies.Note: Patients may have undergone minor surgical procedures with the past three weeks, aslong as all toxicities have recovered to Grade 1 or less.

    Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from

      participation in this study: 1. Have received prior systemic therapy or definitive chemoradiation for the cancer that is being treated on this protocol. Palliative radiation therapy for symptom management, such as to control tumor-induced bleeding, is permitted. 2. Current treatment with another investigational agent. 3. History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study. 4. Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations at the time of treatment that would limit compliance with study requirements. 5. Subjects with HLA-A*02:01 damaging mutation or allele loss detected by research or clinical sequencing will not be eligible. 6. Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations: 1. Clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or 2. Age ≥ 50 years old 7. Participants with baseline screening pulse oxygen level of ≤ 92% on room air will not be eligible. If the underlying cause of hypoxia improves, they may be reevaluated. 8. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR T cells, breastfeeding should be discontinued if the mother is treated with E7 TCR T cells. These potential risks may also apply to other agents used in this study. 9. Participants with a systemic immunodeficiency including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment. 10. Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications). 11. Participants with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus are not eligible. Patients with less severe autoimmune diseases such as hypothyroidism, vitiligo, and other minor autoimmune disorders are eligible. 12. Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or efficacy assessments of the investigational regimen are eligible for this trial. Examples include, but are not limited to: 1. Carcinoma in situ 2. Cutaneous skin cancers requiring only local excision 3. Low grade non-muscle invasive bladder cancer 4. Low grade prostate cancer 13. Subjects who received a live vaccine within 30 days prior to enrollment are not eligible. 14. Determination by the Principal Investigator that participation is not in the best interest of the research subject or may jeopardize the safety of the subject or integrity of the clinical trial data.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute
  • A First-in-Human Study of Mutant-Selective PI3K Alpha Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination with Fulvestrant in Patients with Advanced Breast Cancer. - NCT05216432

    RLY-2608 Single Agent Arm: Primary Objectives: - To determine the MTD and/or RP2D of RLY-2608 as a single agent - To determine the safety and tolerability of RLY-2608 as a single agent RLY-2608 + Fulvestrant Arm: Primary Objectives: - To determine the MTD and/or RP2D of RLY-2608 in combination with fulvestrant - To determine the safety and tolerability of RLY-2608 in combination with fulvestrant Triple Combination Arms: Primary Objectives: - To determine the MTD and/or RP2D of RLY-2608 in combination with CDK4/6 inhibitor (palbociclib or ribociclib) and fulvestrant - To determine the safety and tolerability of RLY-2608 in combination with CDK4/6 inhibitor (palbociclib, ribociclib) and fulvestrant

    View All Details
    • Protocol Number:
      042402

    • Principal Investigator:
      Mridula A George

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Breast

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      RLY-2608

    Read Inclusion & Exclusion Criteria

    Key Inclusion Criteria

      Patient has ECOG performance status of 0-1One or more documented primary oncogenic PIK3CA mutation(s) in blood and/or tumor perlocal assessmentOther potentially oncogenic PIK3CA mutations may be considered but must be approved bythe Sponsor prior to enrollment.Part 1 [Escalation] - Ability to provide archived tumor tissue or be willing to undergopretreatment tumor biopsy to assess PIK3CA status retrospectively Part 2 [Expansion] -Submit tumor tissue prior to study drug initiation for determination of PIK3CA mutationretrospectively.Key Inclusion for RLY-2608 Single Agent Arm
    • [For Part 1: Escalation]: Evaluable disease per RECIST v1.1
    • [For Part 2: Expansion]: Measurable disease per RECIST v1.1
    • Disease that is refractory to standard therapy, intolerant to standard therapy, or has declined standard therapy.
    • Part 1- histologically or cytologically confirmed diagnosis of unresectable or metastatic solid tumor
    • Part 2 - Unresectable or metastatic solid tumor with PIK3CA mutation(s) and one of the following tumor types:Group 1: clear cell ovarian cancer Group 2: head and neck squamous cell carcinoma Group3: cervical cancer Group 4: other solid tumors, excluding colorectal, clear cell ovarian,head and neck squamous cell, and cervical cancers Group 5: unresectable or metastaticsolid tumors with PIK3CA double mutations In addition, the SRC (with Sponsor approval)may choose to open additional group(s) of 20 participants to study the clinical activity,safety, and PK/PD with other specified solid tumor types.Key Inclusion for Combination Arms:
    • Doublet combination arms [Part 1 and Part 2]: Evaluable disease per RECIST v1.1
    • Triplet combination arms:
    • [Part 1 and Part 2 Dose Expansion, Group 1]: Evaluable disease per RECIST.
    • [Part 2 Dose Expansion, Group 2]: Measurable disease per RECIST. Bone-only lytic or lytic/blastic disease with at least 1 measurable soft-tissue component per RECIST may be eligible.
    • [For Part 1 and Part 2]: Male or female with histologically or cytologically confirmed diagnosis of HR+, HER2- unresectable or metastatic breast cancer that is not amenable to curative therapy. Females may be postmenopausal, premenopausal, or perimenopausal. Premenopausal or perimenopausal females must have a histologically or cytologically confirmed diagnosis of HR+ HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy and must have initiated treatment with a gonadotropin-releasing hormone (GnRH) agonist at least 4 weeks prior to start of study drug with continuation of GnRH agonist for the duration of study treatment (GnRH agonist recommended for males).
    • Had previous treatment for breast cancer with: [Does not apply to triplet combination arms, Part 2 Dose Expansion, Group 2]: 1. ≤1 line of chemotherapy in the metastatic setting 2. ≥1 CDK4/6 inhibitor in either the adjuvant and/or metastatic setting 3. ≥1 antiestrogen therapy in either adjuvant and/or metastatic setting, including, but not limited to, selective estrogen-receptor degraders (eg, fulvestrant), selective estrogen receptor modulators (eg, tamoxifen), and aromatase inhibitors (AI) (letrozole, anastrozole, exemestane), and 4. ≥1 PARP inhibitor, if appropriate, if documented germline BRCA1/2 mutation Note: Systemic local, loco-regional, or adjuvant treatment with chemotherapy and PARP inhibitors is not to be included in enumeration or previous treatment[For double combination arm; Part 2 Dose Expansion, Group 2]: Received prior treatmentwith a PI3Kα, AKT, or mTOR inhibitor and discontinued the inhibitor due to intoleranceand not disease progression, where intolerance is defined as treatment discontinuationdue to treatment related AE (eg. hyperglycemia, rash, diarrhea, stomatitis) other thansevere hypersensitivity reaction and/or life-threatening reactions, such as anaphylaxisand Stevens-Johnson syndrome.[For triple combination arms; Part 1 dose escalation]: Participants who had previoustreatment for breast cancer with PI3Kα, AKT, mTOR inhibitors and discontiuned due toparticipant/physician decision, intolerance, or disease progression will be considered.[For triple combination arms, Part 2 Dose Expansion, Group 2]: Participants must beintolerant to or have declined standard therapy for locally advanced or metastaticHR+/HER2- PIK3CA-mutated breast cancer. Prior endocrine therapy and CDK4/6inhibitors areallowed as follows: 1. Participants must have progressed during (neo)adjuvant endocrine therapy or within12 months of completing (neo)adjuvant endocrine therapy with an AI or tamoxifen. 2. If a CDK4/6 inhibitor was included as part of (neo)adjuvant therapy, disease must have recurred/progressed >12 months after completion of the CDK4/6 inhibitor portion of (neo)adjuvant therapy

    Key Exclusion Criteria

      Prior treatment with: 1. PI3Kα, AKT, or mTOR inhibitors (all arms except for doublet RLY-2608 + fulvestrant arm, Part 2, Group 2; and triplet combinations, Part 1 dose escalation). 2. Immune checkpoint inhibitors. 3. Triplet combinations RLY-2608 + CDK4 or CDK4/6 inhibitor + fulvestrant, Part 2 expansion, Group 2 only:i. Prior systemic chemotherapy or antibody drug conjugate for locally advanced ormetastatic disease. ii. Prior CDK2, CDK4, or CDK4/6 inhibitor as treatment for locallyadvanced or metastatic disease.iii. Prior treatment with fulvestrant or any selective ER degrader, with the exception ofpatients who have received fulvestrant or any selective ER degrader as part ofneoadjuvant therapy only and with treatment duration ≤6 months.Type 1 or Type 2 diabetes requiring antihyperglycemic medication, or fasting plasmaglucose ≥140 mg/dL and glycosylated hemoglobin (HbA1c) ≥7.0%.History of allergy or hypersensitivity to any components or excipients of PI3Kinhibitors. For combination arms only: allergy or hypersensitivity to any components orexcipients of fulvestrant, palbociclib, ribociclib, and/or PF-07220060 as appropriate forthe combination.Past medical history of or ongoing ILD, or pneumonitis requiring intervention.Participants with past history of resolved Grade 1 pneumonitis may be considered, exceptin triple combination arms.The following cardiac criteria:
    • Mean resting corrected QT interval (QTc) >460 msec
    • For triple combination arm with ribociclib: Mean QTcF ≥450 msec (this is what we confirmed is shown in the redacted version of the protocol.CNS metastases or primary CNS tumor that is associated with progressive neurologicsymptoms

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute
  • A First-in-Human, Open-Label, Dose Escalation and Expansion Trial of BTX-9341 in Participants with Advanced and/or Metastatic Breast Cancer - NCT06515470

    Primary Objectives: Part A (Dose Escalation) - To evaluate the safety and tolerability of BTX-9341 monotherapy and/or combination therapy with fulvestrant and determine the MTD/MED of BTX-9341. Part B (Dose Expansion) - To obtain preliminary evidence of BTX-9341 efficacy and establish the RP2D of BTX-9341 when administered in combination with fulvestrant Secondary Objectives: Parts A and B (Dose Escalation and Dose Expansion - To characterize the plasma PK profile of R and S isomers following single and multiple doses of BTX-9341 administered as a single agent and/or in combination with fulvestrant - To determine the interconversion rate between the R and S isomers (both active isomers) of BTX-9341 - To determine the efficacy of BTX-9341 administered as a single agent and/or in combination with fulvestrant Part B Only (Dose Expansion) - To further assess the safety and tolerability of BTX-9341 administered in combination with fulvestrant

    View All Details
    • Protocol Number:
      042602

    • Principal Investigator:
      Mridula A George

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Breast

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      BTX-9341

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Metastatic and/or locally advanced HR+/HER2- breast cancer (dose escalation: measurable disease and/or at least 1 lytic or mixed [lytic + sclerotic] bone lesion that can be assessed by CT or MRI or non-measurable disease [including bone lesions]; dose expansion: measurable disease)
    • Dose escalation: (a) received not more than 1 chemotherapy in the metastatic/advanced setting; (b) no limit to the lines of endocrine therapy (monotherapy or combination therapy) in the metastatic setting; (c) received CDK4/6 inhibitor therapy
    • Dose expansion: (a) received not more than 1 chemotherapy in metastatic/advanced setting; (b) received not more than 2 lines of endocrine therapy (monotherapy or combination therapy) and must have been on prior endocrine therapy for at least 6 months before progression; (c) received at most 2 lines of CDK4/6 inhibitor therapy (1 in the adjuvant setting and 1 in the metastatic setting) and must have been on prior CDK4/6 inhibitor therapy for at least 6 months
    • Acceptable hematologic function 1. ANC ≥ 1500 per mL. Note: Use of growth-factors to maintain the ANC criterion is prohibited. 2. Platelet count ≥ 100,000 per mL. Note: Use of transfusions or thrombopoietic agents to achieve the baseline platelet count criterion is prohibited. 3. Hemoglobin ≥ 9.0 g/dL. Note: Packed red blood cell transfusion is allowed up to 14 days prior to trial entry.
    • Acceptable liver function 1. Bilirubin ≤ 2.0 × institutional upper limit of normal (ULN) (or < 3.0 × institutional ULN if Gilbert's disease is present) 2. Alanine transaminase (ALT)/aspartate aminotransferase (AST) ≤ 3.0 × institutional ULN (≤ 5.0 × institutional ULN if liver metastases present) 3. Alkaline phosphatase ≤ 2.5 × institutional ULN (≤ 5.0 × institutional ULN if bone or liver metastases present)
    • Able and willing to sign informed consent
    • Meets all study requirements in the opinion of the Investigator

    Exclusion Criteria:

    • RB1 (retinoblastoma) gene mutation
    • Symptomatic visceral disease
    • Clinical evidence or history of central nervous system metastasis
    • Abnormalities in coagulation, such as bleeding diathesis, or treatment with anticoagulants precluding injections of fulvestrant or luteinizing hormone-releasing hormone (LHRH) agonist

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

  • A First-in-Human, Open-Label, Phase 1/2 Dose-Escalation with Enrichment and Dose-Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of GIM-122 as a Single Agent in Adult Subjects with Advanced Solid Malignancies. - NCT06028074

    Primary Objective Part A and B: - To characterize the safety and tolerability of GIM-122 as a single agent in subjects with programmed cell death protein-1 (PD-1) programmed cell death ligand-1 (PD-L1) refractory/resistant advanced solid tumor malignancies that have a Food and Drug Administration (FDA) approval for anti-PD-1/PD-L1 therapy at time of recruitment. Primary Objectives Dose Expansion (Part B): - To identify a recommended dose for future studies (RP2D) - To assess the anti-tumor activity of GIM-122 as a single agent in subjects with programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) refractory/resistant advanced solid tumor malignancies that have FDA approval for anti-PD-1/PD-L1 therapy at time of recruitment. Secondary Objectives: - To assess safety and tolerability (Part B only) - To characterize the pharmacokinetic (PK) profile of GIM-122 (Part A and Part B) - To assess the emergence and persistence of anti-drug antibodies (ADA) and the mpact on GIM-122 exposure (Part A and Part B) - To assess the change from baseline in tumor tissue markers as potential predictors of efficacy of GIM-122 (Part A and Part B) - To evaluate the preliminary anti-tumor activity of GIM-122 (Part A only)

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    • Protocol Number:
      052401

    • Principal Investigator:
      Sanjay Goel

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      GIM-122

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      General
    • Written informed consent
    • ECOG performance status 0-1.
    • Laboratory assessment 28 days prior to enrollment for assessment of acceptable cardiac, renal and hepatic functions
    • Recommended Double methods of contraception 90-days post treatment Cancer Specific
    • Histologically or cytologically confirmed locally advanced/unresectable or metastatic solid tumor
    • Received FDA approved treatment of PD-1 inhibitor or PD-L1 inhibitor for advance malignant tumors and have progressed/relapsed, are refractory, or intolerant
    • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
    • Had prior therapy with PD-1/PD-L1 inhibitors. Other checkpoint inhibitors (ie, CTLA4, LAG3) are permitted if they did not lead to treatment discontinuation
    • No other lines of therapy that are available

    Exclusion Criteria:

      General
    • Enrolled in any other interventional clinical trial, starting within 4 weeks of the first dose of GIM-122 and throughout the duration of the study, or is receiving other therapy directed at their malignancy
    • Women who are pregnant or breastfeeding
    • History of cardiac issues, pulmonary embolism, active and clinically significant bacterial, fungal, or viral infection ≤ 6 months prior to dosing
    • Contraindications to the imaging assessments or other study procedures that subjects will undergo or any medical or social condition that, in the opinion of the investigator, might place a subject at an increased risk, affect compliance, or confound safety or other clinical study data interpretation Cancer Specific
    • Current second malignancy at other sites
    • Leptomeningeal disease
    • Spinal cord compression
    • Symptomatic or new or enlarging central nervous system (CNS) metastases

    Treatment-specific Exclusion Criteria

    • Ongoing toxicity > Grade 1 from prior therapy according to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
    • Has undergone a major surgery < 1 month prior to administration of GIM-122
    • Has received radiation therapy within 2 weeks prior to administration of GIM-122
    • Has undergone or is anticipated to undergo organ transplantation including allogeneic or autologous stem cell transplantation at any time
    • Has received systemic anti-cancer therapy within 2 weeks and cytotoxic agents that have a major delayed toxicity within 4 weeks, of the first dose of GIM-122
    • Prior treatment with other immune modulating agents within < 4 weeks prior to the first dose of GIM-122.
    • Has a diagnosis of immunodeficiency, either primary or acquired
    • Has received treatment with systemic steroids or any form of immunosuppressive therapy within 14 days prior to administration of GIM-122
    • Has active or prior history of autoimmune disease, including ulcerative colitis and Crohn's disease, or any condition that requires systemic steroids.
    • Has a known severe intolerance to or hypersensitivity reactions to monoclonal antibodies, Fc-bearing proteins, or IV immunoglobulin preparations; prior history of human anti-human antibody response; known allergy to any of the study medications, or excipients in the various formulations of any agent.
    • Has received live vaccines within 30 days of study initiation (inactivated vaccines are allowed; seasonal vaccines should be up to date > 30 days prior to administration of GIM-122).

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute
  • A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study Of Olverembatinib (HQP 1351) In Patients With Chronic Phase Chronic Myeloid Leukemia (POLARIS-2) - NCT06423911

    Primary Objective: To compare the major molecular response (MMR) rate at 24 weeks of olverembatinib versus bosutinib. Secondary Objective: To compare the MMR rate at 96 weeks for olverembatinib versus bosutinib.

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    • Protocol Number:
      022504

    • Principal Investigator:
      Adam Zayac

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Leukemia, not otherwise specified

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      Bosutinib Olverembatinib (HQP 1351)

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      Patients eligible for inclusion in this study must meet all of the following criteria. 1. Age ≥ 18 years old. 2. Diagnosis of CML-CP 3. Part A: Previously treated with at least two approved TKIs Part B: T315I mutation at screening. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2. 5. Written informed consent obtained prior to any screening procedures. 6. Patients with adequate organ functions

    Exclusion Criteria:

      Patients eligible for this study must not meet any of the following criteria. 1. For Part A only: T315I mutation at any time prior to starting study treatment. 2. Active infection that requires systemic drug therapy 3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs 4. Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients. 5. Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients. 6. Pregnant or nursing (lactating) women.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Monmouth Medical Center
    • Jersey City Medical Center
  • A Long-Term Follow-Up Basket Study for Participants Treated with SynKIR Chimeric Antigen Receptor (CAR) T Cell Product. - NCT06701201

    Primary Objective: To monitor the long-term safety of participants that have been infused with a SynKIR CAR T cell product. Secondary Objectives: - To assess the long-term clinical efficacy of SynKIR CAR T cell product - To assess the persistence of SynKIR-modified T cells

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    • Protocol Number:
      012604

    • Principal Investigator:
      Matthew Matasar

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      Participants are eligible to be included in the study only if all of the followingcriteria apply: 1. All adult participants who have received any amount of SynKIR CAR T cell product in a study sponsored by Verismo Therapeutics. 2. Participant is willing and able to comply with the study requirements.

    Exclusion Criteria:

      There are no specific exclusion criteria.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

  • A Long-Term Study for Participants Previously Treated With Ciltacabtagene Autoleucel. - NCT05201781

    To collect long-term follow-up data on delayed adverse events after administration of cilta-cel, and to characterize and understand the long-term safety profile of cilta-cel.

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    • Protocol Number:
      012204

    • Principal Investigator:
      Matthew Matasar

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Multiple Myeloma

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Participants who have received at least one dose of cilta-cel in a Company-sponsored clinical study
    • Participants who have provided informed consent for this study

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute
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