A Phase 1/2 Study of REGN5678 (Anti-PSMAxCD28) With or Without Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-Resistant Prostate Cancer and Other Tumors Associated With PSMA Expression
Condition: Metastatic Castration-resistant Prostate Cancer (mCRPC), Clear Cell Renal Cell Carcinoma (ccRCC)
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT03972657
Sponsor: Regeneron Pharmaceuticals
Phase: Phase 1/Phase 2
Eligibility:
- Age: minimum 18 Years maximum N/A
- Gender: Male
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-6
- 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
View trial on ClinicalTrials.gov