Moffitt Cancer Center: Clinical Trial 20117

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Clinical Trial 20117

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

Phase: Phase I/II
Prinicipal Investigator:

Call 813-745-6100
or 1-800-679-0775 Learn More

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

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) that has progressed within 6 months prior to screening

Has received ≥2 lines of approved systemic therapy for mCRPC, including a second -generation hormonal agent

Adequate organ and bone marrow function

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, 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

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.