RecruitingRecruiting
REGN15505 (PSMAx4-1BB) Alone or in Combination With Cemiplimab or REGN4336 (PSMAxCD3) in Adult Patients With Metastatic Castration-Resistant Prostate Cancer and Clear Cell Renal Cell Carcinoma
NCT07594106 · Regeneron Pharmaceuticals
In plain English
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Official title
Phase 1/2 Study of REGN15505 (a PSMAx4-1BB Bispecific Antibody) Administered Alone or in Combination With Cemiplimab or REGN4336 (a PSMAxCD3 Bispecific Antibody) in Patients With Metastatic Castration-Resistant Prostate Cancer and Clear Cell Renal Cell Carcinoma
About this study
This study is researching a new drug called REGN15505 when used alone or in combination with cemiplimab or in combination with REGN4336 in adult patients with mCRPC and ccRCC. The goal is to explore new ways to treat these cancers by helping immune cells target and destroy cancer cells.
The study will evaluate the use of REGN15505 when administered alone, in combination with cemiplimab, or in combination with REGN4336 for:
* Any side effects of study drugs
* How well the study drugs work
* How much REGN15505, cemiplimab, and REGN4336 are in the blood at different times
* If the body makes antibodies to REGN15505 or REGN4336, which may mean the study drugs will not work as well as expected
* What is the best dose of REGN15505 when administered alone and with cemiplimab and the best dose of REGN15505 and REGN4336 when used in combination
Eligibility criteria
Key Inclusion Criteria:
Participants with mCRPC:
1. Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma
2. mCRPC with PSA value at screening ≥4 ng/mL and that has progressed within 6 months prior to screening as described in the protocol
3. Has received ≥2 lines of prior systemic therapy approved in the metastatic and/or castration-resistant setting as described in the protocol
4. Have had either Orchiectomy or be on Luteinizing Hormone-Releasing Hormone (LHRH) agonist or antagonist therapy with serum testosterone \<50 ng/dL AND agree to stay on LHRH agonist or antagonist therapy during the study
Participants with ccRCC:
5. Men and women with histologically or cytologically confirmed Renal Cell Carcinoma (RCC) with a clear-cell component
6. Diagnosis of metastatic ccRCC with at least 1 measurable lesion via Response evaluation criteria in solid tumors (RECIST) 1.1 criteria
7. Has progressed on or after ≥1 line of prior systemic therapy approved in the metastatic setting. Prior treatment must include an Anti Program Cell Death 1 (PD-1)/ Program Death Ligand 1 (PD-L1) therapy and either ipilimumab and/or a Tyrosine Kinase Inhibitor (TKI)
Key Exclusion Criteria:
For Both mCRPC and ccRCC Cohorts:
1. Has received treatment with an approved systemic therapy (including sipuleucel-T for mCRPC patients) within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities except for laboratory changes as described in the protocol
mCRPC Cohort Only:
2. Has received prior Prostate Specific Membrane Antigen (PSMA)-targeting therapy with the exception of a PSMA-targeting radioligand (eg, 177Lu-PSMA-617)
Note: Other protocol defined inclusion/exclusion criteria apply
Study design
Enrollment target: 265 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-07-20
Estimated completion: 2030-10-27
Last updated: 2026-09-11
Interventions
Drug: REGN15505Drug: REGN15505+CemiplimabDrug: REGN15505+REGN4336
Primary outcomes
- • Occurrence of Dose Limiting Toxicities (DLTs) (Up to 5 years)
- • Occurrence of Treatment-Emergent Adverse Events (TEAEs) (Up to 5 years)
- • Occurrence of Serious Adverse Events (SAEs) (Up to 5 years)
Sponsor
Regeneron Pharmaceuticals · industry
Contacts & investigators
ContactClinical Trials Administrator · contact · clinicaltrials@regeneron.com · 844-734-6643
InvestigatorClinical Trial Management · study_director, Regeneron Pharmaceuticals
All locations (5)
City of Hope PhoenixRecruiting
Goodyear, Arizona, United States
City of HopeRecruiting
Duarte, California, United States
H. Lee Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
City of Hope Chicago, City of Hope Cancer Center ChicagoRecruiting
Zion, Illinois, United States
The University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States