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NOT YET RECRUITING
NCT07850921
PHASE1/PHASE2

REGN21353 Alone or in Combination With Nezastomig for Metastatic Castration-Resistant Prostate Cancer in Adult Participants

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study will test an experimental Regeneron drug called REGN21353 ("study drug") to see if it can help treat previously treated prostate cancer that has spread (also called metastatic castration-resistant prostate cancer or mCRPC). Some participants may get additional experimental drugs in combination with REGN21353. These additional drugs are nezastomig and sarilumab. "Experimental" means that the drugs are being tested and have not been approved for use in prostate cancer by a country's national health agency that gives approval for new medicines to be prescribed. The study is looking at: * What is the best dose of REGN21353 alone and together with nezastomig for treating prostate cancer * What side effects REGN21353 alone and together with nezastomig might cause * How well REGN21353 alone and together with nezastomig works * How much REGN21353 alone and together with nezastomig is in the blood at different times * If the body reacts to REGN21353 alone or together with nezastomig, in a way that may cause them to not work as well * How REGN21353 alone and together with nezastomig could affect prostate cancer, which can help researchers understand why REGN21353 alone or together with nezastomig work better in some than others

Official title: Phase 1/2 Trial of REGN21353 (a STEAP1xCD3 Bispecific Antibody) Administered Alone or in Combination With Nezastomig (a PSMAxCD28 Bispecific Antibody) in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

192

Start Date

2027-06-28

Completion Date

2031-07-28

Last Updated

2026-09-30

Healthy Volunteers

No

Interventions

DRUG

REGN21353

Administered per the protocol

DRUG

Nezastomig

Administered per the protocol

DRUG

Sarilumab Prophylaxis (Contingency)

May be administered as pretreatment, per the protocol