Actively Recruiting
A Phase 1/2 Study of REGN5678 (Anti-PSMAxCD28) With or Without Cemiplimab (Anti-PD-1) in Adults With Metastatic Castration-Resistant Prostate Cancer and Other Tumors Expressing PSMA
Led by Regeneron Pharmaceuticals · Updated on 2025-11-06
345
Participants Needed
21
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of the drug REGN5678 (Nezastomig), alone or combined with cemiplimab, in adults with metastatic castration-resistant prostate cancer (mCRPC) and other tumors that express PSMA. This study includes two parts: dose escalation to find safe REGN5678 doses alone or with cemiplimab, and dose expansion to assess how well these doses shrink tumors. Additional questions include side effects, drug behavior in the body, blood levels of the drugs, and tumor response through immune system activation. The study involves giving REGN5678 with or without cemiplimab to participants in different cohorts based on tumor type and dose phase. Treatment doses are determined during the dose escalation phase. Participants receive these drugs as outlined in the study protocol during both the dose escalation (Part 1) and dose expansion (Part 2) phases. The study is non-randomized and open-label, meaning all participants receive the investigational drugs without placebo. Participants will be monitored through various safety checks including tracking adverse events and laboratory tests for up to five years. Researchers will measure drug concentrations in the blood and track tumor response using prostate-specific antigen (PSA) levels and imaging criteria. The study also observes immune responses and monitors for any serious side effects or dose-limiting toxicities. This comprehensive follow-up allows for long-term assessment of drug safety and tumor effects.
CONDITIONS
Brief Title
A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men with confirmed adenocarcinoma of the prostate without pure small cell carcinoma for mCRPC cohorts
- PSA value at screening of 4 ng/mL or higher with progression within 6 months prior to screening for mCRPC
- Received at least 2 prior systemic therapies approved for metastatic or castration-resistant prostate cancer including second-generation anti-androgen therapy and lutetium-based PSMA radioligand for mCRPC
- Histologically or cytologically confirmed clear cell renal cell carcinoma with at least one measurable lesion for ccRCC cohorts
- Diagnosis of metastatic ccRCC with progression after at least 1 prior approved systemic therapy including PD-1/PD-L1 therapy and ipilimumab or tyrosine kinase inhibitor
You will not qualify if you...
- Received any approved systemic therapy within 3 weeks before dosing or not recovered from acute toxicities
- Received systemic biologic therapy within 5 half-lives before first study dose
- Prior PSMA-targeting therapy except lutetium-based PSMA radioligand for mCRPC
- Prior anti-cancer immunotherapy within 5 half-lives before study therapy for dose escalation phase
- Prior anti-cancer immunotherapy for dose expansion in mCRPC
- Requires ongoing corticosteroid therapy greater than 10 mg prednisone per day within 1 week before first dose
- Recent or ongoing significant autoimmune disease treated with systemic immunosuppressives within 5 years
- History of encephalitis, meningitis, neurodegenerative disease (except mild dementia not affecting daily living), or uncontrolled seizures in the past year
- Uncontrolled infections including HIV, hepatitis B or C, or diagnosis of immunodeficiency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years or until discontinuation
Participants receive REGN5678 with or without cemiplimab as per the study protocol to evaluate safety and effectiveness.
Visits occur according to dosing and safety monitoring schedules during treatment
Duration - Up to 5 years following treatment completion
Participants are monitored for safety and treatment response after completing active treatment.
Periodic visits for long-term safety and response assessments
Trial Site Locations
Total: 21 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
Mayo Clinic
Phoenix, Arizona, United States, 85054
Actively Recruiting
3
University of Arizona
Tucson, Arizona, United States, 85724
Actively Recruiting
4
John Wayne Cancer Institute (JWCI)
Santa Monica, California, United States, 90404
Actively Recruiting
5
Sarah Cannon Research Institute (SCRI)
Denver, Colorado, United States, 80218
Actively Recruiting
6
Yale University Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
7
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
8
Moffitt Cancer Center - McKinley Drive
Tampa, Florida, United States, 33612
Actively Recruiting
9
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
10
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
11
NYU Langone Health Perlmutter Cancer Center
New York, New York, United States, 10016
Actively Recruiting
12
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
13
Columbia University - The Trustees of Columbia University in the City of New York
New York, New York, United States, 10032
Actively Recruiting
14
Montefiore Medical Center
New York, New York, United States, 10461
Actively Recruiting
15
University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center) - Rochester
Rochester, New York, United States, 14642
Actively Recruiting
16
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Withdrawn
17
Oregon Health & Science University (3485 S. Bond)
Portland, Oregon, United States, 97239
Actively Recruiting
18
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
19
Lifespan Cancer Institute
Providence, Rhode Island, United States, 02903
Actively Recruiting
20
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
21
Emily Couric Clinical Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
C
Clinical Trials Administrator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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