Recent Updates
Recently added Catalysts

REGN15505

Phase 1

Metastatic Castration-Resistant Prostate Cancer (mCRPC) | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: Aug 5, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment265

FDA Designations

No designations recorded

Clinical trial landscape

REGN15505 · 1 trial · 2 indications

Phase 1 1
NCT07594106REGN15505 (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 CarcinomaMetastatic Castration-Resistant Prostate Cancer (mCRPC)
RECRUITING265 Analytics
PHASE1RECRUITING
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
Metastatic Castration-Resistant Prostate Cancer (mCRPC)Unlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence of Dose Limiting Toxicities (DLTs)
Up to 5 years

Dose Escalation

Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Up to 5 years

Dose Escalation

Occurrence of Serious Adverse Events (SAEs)
Up to 5 years

Dose Escalation

Occurrence of Adverse Events of Special Interest (AESIs)
Up to 5 years

Dose Escalation

Composite Response (CompR) based on ≥50% decline of Prostate Specific Antigen (PSA) and/or confirmed radiographic assessment of complete response (CR) or partial response (PR)
Up to 5 years

Dose Expansion-mCRPC

Objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Up to 5 years

Dose Expansion-ccRCC

Secondary Endpoints

Occurrence of TEAEs
Up to 5 years
Occurrence of SAEs
Up to 5 years
Occurrence of AESIs
Up to 5 years
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Module 1: MonotherapyEXPERIMENTALREGN15505
Module 2: Combination 1EXPERIMENTALREGN15505 and Cemiplimab
Module 3: Combination 2EXPERIMENTALREGN15505 and REGN4336

Interventions

NameTypeDescription
REGN15505DRUGAdministered per protocol
REGN15505+CemiplimabDRUGAdministered per protocol
REGN15505+REGN4336DRUGAdministered per protocol
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

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 proto...

Countries:United States
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

LOWAug 5, 2026NCT07594106Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about REGN15505

What is REGN15505 used for?

REGN15505 is an investigational small molecule being developed by Regeneron Pharmaceuticals for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and clear cell renal cell carcinoma (ccRCC). It is currently in Phase 1 clinical development and is not yet approved by the FDA.

Who makes REGN15505?

REGN15505 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN. The drug is currently in Phase 1 clinical trials for metastatic castration-resistant prostate cancer and clear cell renal cell carcinoma.

What phase is REGN15505 in?

REGN15505 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA and is still being studied in clinical trials. The drug is being evaluated for safety and efficacy in patients with metastatic castration-resistant prostate cancer and clear cell renal cell carcinoma.

What clinical trials is REGN15505 in?

REGN15505 is being studied in a Phase 1 clinical trial with the identifier NCT07594106. This trial is recruiting participants in the United States and is evaluating REGN15505 alone or in combination with cemiplimab or REGN4336 in adult patients with metastatic castration-resistant prostate cancer and clear cell renal cell carcinoma.

Is REGN15505 the same as PSMAx4-1BB?

Yes, REGN15505 is also known as PSMAx4-1BB, as indicated in the clinical trial title. The drug is being studied for its potential to target PSMA and 4-1BB pathways in the treatment of metastatic castration-resistant prostate cancer and clear cell renal cell carcinoma.