Clinical Trial 20117

Cancer Type: Genitourinary
Study Type: Treatment
NCT#: NCT03972657

Phase: Phase I/II
Principal Investigator: Zhang, Jingsong

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Overview

Study Title

A Phase 1/2 Study of Regn5678 (Anti-psmaxcd28) with Cemiplimab (Anti-pd-1) in Patients with Metastatic Castration-Resistant Prostate Cancer

Summary

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.

Objective

The primary objectives of the study are: Dose Escalation: To evaluate safety, tolerability, and pharmacokinetics (PK) of REGN5678 alone and in combination with cemiplimab Dose Expansion: 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

Treatments

Therapies

Therapy (NOS)

Medications

Cemiplimab (); REGN2810 (Cemiplimab); REGN5678 ()

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

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

Exclusion Criteria

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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