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

  • End date
    Aug 4, 2026
  • participants needed
  • sponsor
    Regeneron Pharmaceuticals
Updated on 10 September 2023


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

Condition Metastatic Castration-resistant Prostate Cancer
Treatment 18F-DCFPyL, Cemiplimab, REGN4336
Clinical Study IdentifierNCT05125016
SponsorRegeneron Pharmaceuticals
Last Modified on10 September 2023


Yes No Not Sure

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)

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
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