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REGN15505

Phase 1

Metastatic Castration-Resistant Prostate Cancer (mCRPC) | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: May 18, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment265
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
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 CarcinomaPHASE1 NOT YET_RECRUITING 265 — — May 25, 2026Sep 20, 2030May 18, 2026 - —
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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
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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
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

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...

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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07594106studyFirstPostDate: changed
LOWMay 21, 2026NCT07594106NEW_TRIAL: changed
LOWMay 21, 2026NCT07594106NEW_TRIAL: changed