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RecruitingPhase 1 / Phase 2

REGN15505 (PSMAx4-1BB) Alone or in Combination With Cemiplimab or REGN4336 (PSMAxCD3) in Adult Patients With Metastatic Castration-Resistant Prostate Cancer and Clear Cell Renal Cell Carcinoma

Phase 1/2 Study of REGN15505 (a PSMAx4-1BB Bispecific Antibody) Administered Alone or in Combination With Cemiplimab or REGN4336 (a PSMAxCD3 Bispecific Antibody) in Patients With Metastatic Castration-Resistant Prostate Cancer and Clear Cell Renal Cell Carcinoma

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests REGN15505 alone or with cemiplimab or REGN4336 to help immune cells attack cancer. It is for adults with prostate cancer that has spread and keeps growing despite low testosterone, or clear cell kidney cancer that has spread. Researchers will study side effects, how well the drugs work, and the best doses.

This study is researching a new drug called REGN15505 when used alone or in combination with cemiplimab or in combination with REGN4336 in adult patients with mCRPC and ccRCC. The goal is to explore new ways to treat these cancers by helping immune cells target and destroy cancer cells. The study will evaluate the use of REGN15505 when administered alone, in combination with cemiplimab, or in combination with REGN4336 for: * Any side effects of study drugs * How well the study drugs work * How much REGN15505, cemiplimab, and REGN4336 are in the blood at different times * If the body makes antibodies to REGN15505 or REGN4336, which may mean the study drugs will not work as well as expected * What is the best dose of REGN15505 when administered alone and with cemiplimab and the best dose of REGN15505 and REGN4336 when used in combination

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • For prostate cancer: Men must have prostate cancer confirmed by tissue or cell tests. It cannot be only the small cell type.
  • Prostate cancer must have spread, keep growing despite low testosterone, and have worsened in the past 6 months. The PSA blood test must be at least 4 ng/mL.
  • For prostate cancer: Have had at least 2 approved drug treatments for cancer that has spread or keeps growing despite low testosterone.
  • For prostate cancer: Have had surgery to remove the testicles or take medicine to lower testosterone. Testosterone must be below 50 ng/dL. Those taking this medicine must stay on it during the study.
  • For kidney cancer: Men and women must have kidney cancer with clear cells, confirmed by tissue or cell tests.
  • Kidney cancer must have spread and have at least 1 tumor that can be measured using the study's rules.
  • Kidney cancer must have worsened during or after at least 1 approved drug treatment for cancer that has spread. Past treatment must include a PD-1 or PD-L1 drug, which helps the immune system fight cancer, plus ipilimumab, a TKI drug that blocks cancer growth signals, or both.

Who can't join

  • For either cancer: Had an approved cancer drug treatment that works throughout the body within 3 weeks before study dosing. This includes sipuleucel-T for prostate cancer.
  • For either cancer: Still have short-term side effects from past treatment that are more than mild and have not returned to their usual level. Some lab test changes may be allowed under study rules.
  • For prostate cancer: Had treatment targeting PSMA, a protein on prostate cancer cells. PSMA treatments that deliver radiation, such as 177Lu-PSMA-617, are allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: Participants with mCRPC: 1. Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma 2. mCRPC with PSA value at screening ≥4 ng/mL and that has progressed within 6 months prior to screening as described in the protocol 3. Has received ≥2 lines of prior systemic therapy approved in the metastatic and/or castration-resistant setting as described in the protocol 4. Have had either Orchiectomy or be on Luteinizing Hormone-Releasing Hormone (LHRH) agonist or antagonist therapy with serum testosterone \<50 ng/dL AND agree to stay on LHRH agonist or antagonist therapy during the study Participants with ccRCC: 5. Men and women with histologically or cytologically confirmed Renal Cell Carcinoma (RCC) with a clear-cell component 6. Diagnosis of metastatic ccRCC with at least 1 measurable lesion via Response evaluation criteria in solid tumors (RECIST) 1.1 criteria 7. Has progressed on or after ≥1 line of prior systemic therapy approved in the metastatic setting. Prior treatment must include an Anti Program Cell Death 1 (PD-1)/ Program Death Ligand 1 (PD-L1) therapy and either ipilimumab and/or a Tyrosine Kinase Inhibitor (TKI) Key Exclusion Criteria: For Both mCRPC and ccRCC Cohorts: 1. Has received treatment with an approved systemic therapy (including sipuleucel-T for mCRPC patients) within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities except for laboratory changes as described in the protocol mCRPC Cohort Only: 2. Has received prior Prostate Specific Membrane Antigen (PSMA)-targeting therapy with the exception of a PSMA-targeting radioligand (eg, 177Lu-PSMA-617) Note: Other protocol defined inclusion/exclusion criteria apply

Study sites (6)

AZ

CA

FL

IL

MO

TX