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
NCT07594106 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 265
Last updated 2026-05-18
Summary
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
Conditions
- Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Clear Cell Renal Cell Carcinoma (ccRCC)
Interventions
- DRUG
-
REGN15505
Administered per protocol
- DRUG
-
REGN15505+Cemiplimab
Administered per protocol
- DRUG
-
REGN15505+REGN4336
Administered per protocol
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-25
- Primary Completion
- 2030-09-20
- Completion
- 2030-09-20
- FDA Drug
- Yes
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