Prostate Cancer Clinical Trial
Study of REGN5678 (Anti-PSMAxCD28) With or Without Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-resistant Prostate Cancer and Other Tumors
The primary objectives of the study in Dose Escalation are to evaluate safety, tolerability, and pharmacokinetics (PK) of REGN5678 alone and in combination with cemiplimab and in Dose Expansion are to assess efficacy, as measured by objective response rate (ORR) per modified Prostate Cancer Working Group 3 (PCWG3) criteria, of REGN5678 in combination with cemiplimab.
The secondary objectives of the study in Dose Escalation are to assess efficacy, as measured by ORR per modified PCWG3 criteria, of REGN5678 in combination with cemiplimab and in Dose Expansion are to characterize the safety profile in each expansion cohort and to characterize the PK of REGN5678 in combination with cemiplimab. Secondary objectives in both Dose Escalation and Dose Expansion are to assess efficacy of REGN5678 in combination with cemiplimab, as measured by additional criteria and to assess immunogenicity of REGN5678 in combination with cemiplimab.
Key Inclusion Criteria:
Histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma (mCRPC cohorts).
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 (mCRPC cohorts).
(mCRPC cohorts) Has received ≥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 (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)
(post-177Lu-PSMA-617 radiotherapy expansion cohort only) Has received at least 2 doses of 177Lu-PSMA-617. Prior therapy 177Lu-PSMA-617 is not permitted in other cohorts
Histologically or cytologically confirmed RCC with a clear-cell component.
Diagnosis of metastatic ccRCC with at least one measurable lesion via RECIST 1.1 criteria
Tumor PSMA expression via PSMA-positron emission tomography (PET), as defined by at least one PSMA-PET positive lesion with signal above liver background via visual assessment per central review
Has progressed on or after ≥1 line prior systemic therapy approved in the metastatic setting. Prior treatment must include an anti-programmed death-1 (receptor) [PD-1]/programmed death-ligand 1 (PD-L1) therapy and either ipilimumab and/or a tyrosine kinase inhibitor
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
Dose Expansion (mCRPC only): Has had prior anti-cancer immunotherapy
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
- At this time, we are only enrolling the REGN5678 monotherapy expansion cohort
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There are 13 Locations for this study
Tucson Arizona, 85704, United States
Santa Monica California, 90404, United States
Denver Colorado, 80218, United States
New Haven Connecticut, 06520, United States
Tampa Florida, 33612, United States
Boston Massachusetts, 02114, United States
New York New York, 10016, United States
New York New York, 10029, United States
New York New York, 10032, United States
Portland Oregon, 97213, United States
Philadelphia Pennsylvania, 19107, United States
Providence Rhode Island, 02903, United States
Houston Texas, 77030, United States
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