Actively Recruiting
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
Led by Regeneron Pharmaceuticals · Updated on 2025-11-06
345
Participants Needed
21
Research Sites
431 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug\[s\]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) alone, or in combination with cemiplimab. The study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors. This study is looking at several other research questions, including: 1. Side effects that may be experienced by taking REGN5678 alone or in combination with cemiplimab 2. How REGN5678 alone or in combination with cemiplimab works in the body 3. How much REGN5678 and/or cemiplimab are present in the blood 4. To see if REGN5678 alone or in combination with cemiplimab works to reduce the size of the tumor by helping the immune system destroy the tumor
CONDITIONS
Official 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
- PSA value at screening of 4 ng/mL or higher with progression within 6 months prior to screening
- Received at least 2 prior systemic therapies for metastatic or castration-resistant prostate cancer including one second-generation anti-androgen therapy and lutetium-based PSMA radiotherapy
- Histologically or cytologically confirmed clear cell renal cell carcinoma
- Diagnosis of metastatic ccRCC with at least one measurable lesion by RECIST 1.1 criteria
- Progressed on or after at least one prior approved systemic therapy for metastatic ccRCC including anti-PD-1/PD-L1 therapy and ipilimumab and/or tyrosine kinase inhibitor
You will not qualify if you...
- Received approved systemic therapy within 3 weeks of dosing or not recovered from acute toxicities
- Received systemic biologic therapy within 5 half-lives before first dose
- Received prior PSMA-targeting therapy except lutetium-based PSMA radioligand in mCRPC
- Prior anti-cancer immunotherapy within 5 half-lives before study therapy (Dose Escalation) or prior anti-cancer immunotherapy as specified (Dose Expansion mCRPC)
- Requires ongoing corticosteroid therapy exceeding 10 mg prednisone/day within 1 week before first dose
- Has ongoing or recent (within 5 years) significant autoimmune disease needing systemic immunosuppressive treatment
- History of encephalitis, meningitis, neurodegenerative disease (except mild dementia not affecting daily living), or uncontrolled seizures within 1 year prior to first dose
- Uncontrolled HIV, hepatitis B or C infection, or immunodeficiency
AI-Screening
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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
CONTACT
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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