A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With Cemiplimab for Adult Participants With Advanced Prostate Cancer

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Trial ID: NCT05125016

Purpose

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

Official Title

Phase 1/2 Study of REGN4336 (a PSMAXCD3 Bispecific Antibody) Administered Alone or in Combination With Cemiplimab in Patients With Metastatic Castration-Resistant Prostate Cancer

Stanford Investigator(s)

Sandy Srinivas
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology

Eligibility


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 that has progressed within 6 months prior to screening as defined in the
   protocol

   3. 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:

   1. 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

   2. Has received any previous systemic biologic therapy within 5 half-lives of first dose
   of study therapy

   3. Has received prior PSMA-targeting therapy

   4. 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

   5. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that
   required treatment with systemic immunosuppressive treatments

   6. 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

   7. 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

Intervention(s):

drug: REGN4336

drug: Cemiplimab

other: 18F-DCFPyL

Recruiting

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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Noel Del Toro
650-723-0574

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