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
NCT ID: NCT03972657
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
345 participants
INTERVENTIONAL
2019-08-12
2027-11-15
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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mCRPC - dose escalation cohort
REGN5678 with or without cemiplimab
REGN5678
Administered as per the protocol
Cemiplimab
Administered as per the protocol
mCRPC - dose expansion cohort
REGN5678 with or without cemiplimab
REGN5678
Administered as per the protocol
ccRCC - dose escalation cohort
REGN5678 with or without cemiplimab
REGN5678
Administered as per the protocol
Cemiplimab
Administered as per the protocol
ccRCC - dose expansion cohort
REGN5678 with or without cemiplimab
REGN5678
Administered as per the protocol
Interventions
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REGN5678
Administered as per the protocol
Cemiplimab
Administered as per the protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma.
2. PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening as defined in the protocol.
3. Has received ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting (in addition to Androgen Deprivation Therapy \[ADT\]) including at least:
1. one second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)
2. 177Lu-PSMA-617 radiotherapy, or another lutetium-based PSMA targeted radioligand, as described in the protocol
ccRCC cohorts (men and women):
1. Histologically or cytologically confirmed RCC with a clear-cell component.
2. Diagnosis of metastatic ccRCC with at least one measurable lesion via RECIST 1.1 criteria
3. Has progressed on or after ≥1 line prior systemic therapy approved in the metastatic setting. Prior treatment must include an anti-Programmed Death-1 (receptor) \[PD-1\]/Programmed Death-Ligand 1 (PD-L1) therapy and either ipilimumab and/or a tyrosine kinase inhibitor
Exclusion Criteria
2. Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy, as described in the protocol
3. Has received prior PSMA-targeting therapy with the exception of a PSMA targeting radioligand (eg. 177Lu-PSMA-617) in mCRPC
4. Dose Escalation: Has had prior anti-cancer immunotherapy (other than sipuleucel-T) within 5 half-lives prior to study therapy.
5. Dose Expansion (mCRPC only): Has had prior anti-cancer immunotherapy, as described in the protocol
6. 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
7. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, as described in the protocol
8. Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with Activities of Daily Living \[ADLs\]) or uncontrolled seizures in the year prior to first dose of study therapy
9. Uncontrolled infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Mayo Clinic
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
John Wayne Cancer Institute (JWCI)
Santa Monica, California, United States
Sarah Cannon Research Institute (SCRI)
Denver, Colorado, United States
Yale University Hospital
New Haven, Connecticut, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Moffitt Cancer Center - McKinley Drive
Tampa, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
NYU Langone Health Perlmutter Cancer Center
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University - The Trustees of Columbia University in the City of New York
New York, New York, United States
Montefiore Medical Center
New York, New York, United States
University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center) - Rochester
Rochester, New York, United States
Providence Portland Medical Center
Portland, Oregon, United States
Oregon Health & Science University (3485 S. Bond)
Portland, Oregon, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Lifespan Cancer Institute
Providence, Rhode Island, United States
MD Anderson Cancer Center
Houston, Texas, United States
Emily Couric Clinical Cancer Center
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Other Identifiers
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R5678-ONC-1879
Identifier Type: -
Identifier Source: org_study_id
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