TrialPath
← Back to searchRecruiting

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

NCT03972657 · Regeneron Pharmaceuticals
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
A Phase 1/2 Study of REGN5678 (Anti-PSMAxCD28) With or Without Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-Resistant Prostate Cancer and Other Tumors Associated With PSMA Expression
About this study
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
Eligibility criteria
Key Inclusion Criteria: mCRPC cohorts (men): 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 Key Exclusion Criteria: 1. 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, as described in the protocol 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 NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
Study design
Enrollment target: 345 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2019-08-12
Estimated completion: 2027-11-15
Last updated: 2025-11-06
Interventions
Drug: REGN5678Drug: Cemiplimab
Primary outcomes
  • Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) (Through study completion, up to 5 years)
  • Incidence and severity of Adverse Event of Special Interests (AESIs) (Through study completion, up to 5 years)
  • Incidence and severity of Serious Adverse Events (SAEs) (Through study completion, up to 5 years)
Sponsor
Regeneron Pharmaceuticals · industry
Contacts & investigators
ContactClinical Trials Administrator · contact · clinicaltrials@regeneron.com · 844-734-6643
InvestigatorClinical Trials Management · study_director, Regeneron Pharmaceuticals
All locations (21)
Banner MD Anderson Cancer CenterRecruiting
Gilbert, Arizona, United States
Mayo ClinicRecruiting
Phoenix, Arizona, United States
University of ArizonaRecruiting
Tucson, Arizona, United States
John Wayne Cancer Institute (JWCI)Recruiting
Santa Monica, California, United States
Sarah Cannon Research Institute (SCRI)Recruiting
Denver, Colorado, United States
Yale University HospitalRecruiting
New Haven, Connecticut, United States
Mayo Clinic JacksonvilleRecruiting
Jacksonville, Florida, United States
Moffitt Cancer Center - McKinley DriveRecruiting
Tampa, Florida, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
NYU Langone Health Perlmutter Cancer CenterRecruiting
New York, New York, United States
Icahn School of Medicine at Mount SinaiRecruiting
New York, New York, United States
Columbia University - The Trustees of Columbia University in the City of New YorkRecruiting
New York, New York, United States
Montefiore Medical CenterRecruiting
New York, New York, United States
University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center) - RochesterRecruiting
Rochester, New York, United States
Providence Portland Medical CenterWithdrawn
Portland, Oregon, United States
Oregon Health & Science University (3485 S. Bond)Recruiting
Portland, Oregon, United States
Thomas Jefferson University HospitalRecruiting
Philadelphia, Pennsylvania, United States
Lifespan Cancer InstituteRecruiting
Providence, Rhode Island, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Emily Couric Clinical Cancer CenterRecruiting
Charlottesville, Virginia, United States
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 · TrialPath