Study of REGN5678 (Anti-PSMAxCD28) With Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-resistant Prostate Cancer
Study Phase: Phase 1/Phase 2
Recruitment Status: Recruiting
Start Date: August 12, 2019
End Date: July 16, 2024
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/mLthat has progressed within 6 months prior to screening as defined in the protocol
- 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) 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 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
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Conditions:
- Prostatic Neoplasms