A Phase 1/2 Study of Regn5678 (Anti-psmaxcd28) with Cemiplimab (Anti-pd-1) in Patients with Metastatic Castration-Resistant Prostate Cancer
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 primary objectives of the study are:
To evaluate safety, tolerability, and pharmacokinetics (PK) of REGN5678 alone and in combination with cemiplimab
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
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
Has received >2 lines prior systemic therapy (in addition to androgen deprivation therapy [ADT]) with at least:
One line of a second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide) in the metastatic and/or castration-resistant setting OR;
One additional systemic line of therapy approved for metastatic and/or castration-resistant disease
NOTE: a non-taxane based chemotherapy regimen given for metastatic prostate cancer with mixed histology is permissible and will be included when evaluating line of therapy
Able and willing to provide tumor tissue, either archival or newly obtained. NOTE: For dose escalation only, if archival or fresh tissue is not available, a pathology report that confirms diagnosis of prostate cancer may be submitted.
Have had either orchiectomy OR be on luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy with serum testosterone >Adequate organ and bone marrow function
Has received treatment with an approved systemic therapy (including sipuleucel-T) within 3 weeks of dosing or has not yet recovered (ie, grade >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, organic brain disease (eg, Parkinson's disease) 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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