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

This study is researching an investigational drug called REGN4336 both alone or together with another investigational drug called REGN5678. The study is focused on participants with previously treated metastatic prostate cancer. The main purpose of the study is to look at the safety, tolerability (how the body reacts to the drug) and effectiveness (how well the drug works to shrink tumors) of REGN4336 when given in combination with REGN5678. The study has 2 parts. The purpose of Part 1 is to determine a safe dose(s) of REGN4336 to be given alone or in combination with REGN5678. Part 1 is kno

Trial Details

NCT ID

NCT05125016

Phase

PHASE1 / PHASE2

Sponsor

Regeneron Pharmaceuticals

Status

RECRUITING

Cancer Type

Prostate Cancer

Interventions

REGN4336
REGN5678

Locations (sample)

Palo Alto, California, United States|37.44188,-122.14302
New Haven, Connecticut, United States|41.30815,-72.92816
Louisville, Kentucky, United States|38.25424,-85.75941
Baltimore, Maryland, United States|39.29038,-76.61219
New Brunswick, New Jersey, United States|40.48622,-74.45182

Key Eligibility Criteria

Histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma
Metastatic, Castration-Resistant Prostate Cancer (mCRPC) with PSA value at screening ≥4 ng/mL and that has progressed within 6 months prior to scre…
PSA progression as defined by a rising PSA level confirmed with an interval of ≥1 week between each assessment
Radiographic disease progression in soft tissue based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria with or without…

For full eligibility, visit ClinicalTrials.gov.

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