Clinical trial for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Official title 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
ClinicalTrials.gov ID: NCT07594106
What this study is testing
What is REGN15505?
an investigational drug being studied as a potential treatment for metastatic castration‑resistant prostate cancer (mCRPC) and clear cell renal cell carcinoma (ccRCC).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how safe the drugs are, how they behave in the body, and what dose works best. It also looks at whether the drugs help the immune system attack the cancers.
- Who it's for
- Adults with metastatic castration‑resistant prostate cancer or clear cell renal cell carcinoma.
- What's involved
- Participants receive REGN15505 by itself, with cemiplimab, or with REGN4336, plus regular blood tests and safety checks.
- Time commitment
- The trial runs for several months with multiple clinic visits for dosing and monitoring.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma
- mCRPC with PSA value at screening ≥4 ng/mL and that has progressed within 6 months prior to screening as described in the protocol
- Has received ≥2 lines of prior systemic therapy approved in the metastatic and/or castration-resistant setting as described in the protocol
- Men and women with histologically or cytologically confirmed Renal Cell Carcinoma (RCC) with a clear-cell component
- Diagnosis of metastatic ccRCC with at least 1 measurable lesion via Response evaluation criteria in solid tumors (RECIST) 1.1 criteria
You likely can't join if
- Has received prior Prostate Specific Membrane Antigen (PSMA)-targeting therapy with the exception of a PSMA-targeting radioligand (eg...
See the full eligibility criteria
- Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma
- mCRPC with PSA value at screening ≥4 ng/mL and that has progressed within 6 months prior to screening as described in the protocol
- Has received ≥2 lines of prior systemic therapy approved in the metastatic and/or castration-resistant setting as described in the protocol
- Men and women with histologically or cytologically confirmed Renal Cell Carcinoma (RCC) with a clear-cell component
- Diagnosis of metastatic ccRCC with at least 1 measurable lesion via Response evaluation criteria in solid tumors (RECIST) 1.1 criteria
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Goodyear, Arizona, United States
- Duarte, California, United States
- Tampa, Florida, United States
- Zion, Illinois, United States
- St Louis, Missouri, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Goodyear, Arizona, United States; Duarte, California, United States; Tampa, Florida, United States; Zion, Illinois, United States; St Louis, Missouri, United States; Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.