Prostate Cancer Clinical Trial

REGN4336 (a PSMAXCD3 Bispecific Antibody) Administered Alone or in Combination With Cemiplimab in Adult Male Patients With Metastatic Castration-Resistant Prostate Cancer

Summary

The primary objective of the study is:

Dose Escalation:

• To assess the safety, tolerability, and pharmacokinetics (PK) and to determine recommended phase 2 dosing regimen (RP2DR) of REGN4336 separately as monotherapy or in combination with cemiplimab

Dose Expansion:

• To assess preliminary anti-tumor activity of REGN4336 as monotherapy or in combination with cemiplimab as measured by objective response rate (ORR) per modified Prostate Cancer Working Group (PCWG3) criteria

The secondary objectives of the study are:

Dose Escalation:

• To assess preliminary anti-tumor activity of REGN4336 as monotherapy or in combination with cemiplimab as measured by ORR per modified PCWG3 criteria

Dose Expansion:

To characterize the safety profile in each expansion cohort
To characterize the PK of REGN4336 as monotherapy or in combination with cemiplimab

In both Dose Escalation and Dose Expansion:

To assess preliminary anti-tumor activity of REGN4336 as monotherapy or in combination with cemiplimab as measured by prostate specific antigen (PSA) decline
To evaluate immunogenicity of REGN4336 in Module 1 and immunogenicity of REGN4336 and cemiplimab in Module 2

View Eligibility Criteria

Eligibility Criteria

Key Inclusion 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 that has progressed within 6 months prior to screening as defined in the protocol
Has progressed upon or intolerant to ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting (in addition to androgen deprivation therapy [ADT]) including at least one second-generation anti-androgen therapy (e.g. abiraterone, enzalutamide, apalutamide, or darolutamide)

Key Exclusion Criteria:

Has received treatment with an approved systemic therapy within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities
Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy
Has received prior PSMA-targeting therapy
Any condition that requires ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study therapy
Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with activities of daily living [ADLs]) or uncontrolled seizures in the year prior to first dose of study therapy
Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency

NOTE: Other protocol defined Inclusion/Exclusion Criteria apply

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

199

Study ID:

NCT05125016

Recruitment Status:

Recruiting

Sponsor:

Regeneron Pharmaceuticals

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There are 9 Locations for this study

See Locations Near You

Stanford Cancer Center
Palo Alto California, 94304, United States
Norton Cancer Institute
Louisville Kentucky, 40207, United States
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore Maryland, 21201, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia Pennsylvania, 19104, United States
Thomas Jefferson University, Sidney Kimmel Center, Clinical Research Organization
Philadelphia Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Froedtert and Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

199

Study ID:

NCT05125016

Recruitment Status:

Recruiting

Sponsor:


Regeneron Pharmaceuticals

How clear is this clinincal trial information?

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