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REGN4336

Phase 1

Metastatic Castration-resistant Prostate Cancer | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: May 5, 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 Enrollment228
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05125016A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With REGN5678 for Adult Participants With Advanced Prostate CancerPHASE1 RECRUITING 228 — — Nov 30, 2021Mar 28, 2030May 5, 202614 United States
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Study Endpoints
Primary Endpoints
Incidence of Dose-Limiting Toxicities (DLTs)
up to 21 days

Dose escalation

Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
Up to 5 years

Dose escalation

Incidence and severity of Serious Adverse Events (SAEs)
Up to 5 years

Dose escalation

Incidence and severity of Adverse Events of Special Interest (AESIs)
Up to 5 years

Dose escalation

REGN4336 monotherapy concentrations in serum
Up to 5 years

Dose escalation

REGN4336 concentrations in serum in combination with REGN5678
Up to 5 years

Dose escalation

Composite Response Rate (CRR) of ≥50% decline of prostate specific antigen (PSA) and/or confirmed radiographic response of complete response (CR) or partial response (PR)
Up to 5 years

Dose expansion

Secondary Endpoints
CRR of ≥50% decline of PSA and/or confirmed radiographic response of CR or PR
Up to 5 years
Anti-Drug Antibodies (ADA) to REGN4336
Up to 5 years
ADA to REGN4336 and REGN5678
Up to 5 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Module 1- MonotherapyEXPERIMENTAL -
Module 3-Combo TherapyEXPERIMENTAL -
Interventions
NameTypeDescription
REGN4336DRUGAdministered per the protocol
REGN5678DRUGAdministered per the protocol
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites14

Key Inclusion Criteria: 1. Histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma 2. Metastatic, Castration-Resistant Prostate Cancer (mCRPC) with PSA value at screening ≥4 ng/mL and that has progressed within 6 months prior to screening, accordin...

Countries:United States
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Recent Changes (Last 90 Days)
HIGHMay 26, 2026NCT05125016Enrollment: 370 → 228
LOWMay 24, 2026NCT05125016studyFirstPostDate: changed