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REGN4336

Phase 1

Metastatic Castration-resistant Prostate Cancer | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: May 5, 2026

Target and mechanism

Molecular targetPSMA
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment228

FDA Designations

No designations recorded

Clinical trial landscape

REGN4336 · 1 trial · 1 indication

Phase 1 1
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 CancerMetastatic Castration-resistant Prostate Cancer
RECRUITING228 Analytics
PHASE1RECRUITING
A 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 Cancer
Metastatic Castration-resistant Prostate CancerUnlock trial analytics

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 to 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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Frequently asked questions about REGN4336

What is REGN4336 used for in Metastatic Castration-resistant Prostate Cancer?

REGN4336 is an investigational small molecule being studied for the treatment of metastatic castration-resistant prostate cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being evaluated alone and in combination with REGN5678 in adult participants with advanced prostate cancer.

What does REGN4336 target?

REGN4336 targets PSMA, a protein that is commonly expressed on prostate cancer cells. By targeting PSMA, the drug aims to interfere with cancer cell activity. This mechanism is being investigated in a Phase 1 clinical trial for metastatic castration-resistant prostate cancer.

Who makes REGN4336?

REGN4336 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker REGN. The company is currently conducting a Phase 1 clinical trial to evaluate the safety and efficacy of REGN4336 in patients with advanced prostate cancer.

What phase is REGN4336 in?

REGN4336 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is recruiting participants with metastatic castration-resistant prostate cancer to assess the drug's safety and how well it works, both alone and in combination with REGN5678.

What clinical trials is REGN4336 in?

REGN4336 is being studied in a Phase 1 clinical trial with the identifier NCT05125016. This trial is recruiting 228 adult male participants with metastatic castration-resistant prostate cancer in the United States. The study is evaluating REGN4336 alone and in combination with REGN5678, and is currently active and recruiting.