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Clinical Trials in Egypt / NCT07594106
Recruiting Phase 1/2

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 · tracked via the Priya Life Science Egypt tracker
Sponsor
Regeneron Pharmaceuticals
Phase
Phase 1/2
Started
2026-07-20
Last updated
2026-09-28

Condition(s) studied

Metastatic Castration-Resistant Prostate Cancer (mCRPC)Clear Cell Renal Cell Carcinoma (ccRCC)

Investigational drug(s) / intervention(s)

REGN15505REGN15505+Cemiplimab →REGN15505+REGN4336 →

REGN15505: Administered per protocol

REGN15505+Cemiplimab: Administered per protocol

REGN15505+REGN4336: Administered per protocol

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Occurrence of Dose Limiting Toxicities (DLTs) — Up to 5 years
    Dose Escalation
  • Occurrence of Treatment-Emergent Adverse Events (TEAEs) — Up to 5 years
    Dose Escalation
  • Occurrence of Serious Adverse Events (SAEs) — Up to 5 years
    Dose Escalation
  • Occurrence of Adverse Events of Special Interest (AESIs) — Up to 5 years
    Dose Escalation
  • Composite Response (CompR) based on ≥50% decline of Prostate Specific Antigen (PSA) and/or confirmed radiographic assessment of complete response (CR) or partial response (PR) — Up to 5 years
    Dose Expansion-mCRPC
  • Objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 — Up to 5 years
    Dose Expansion-ccRCC

Trial sites (6)

FacilityCityRegionStatus
City of Hope Phoenix Goodyear Arizona Recruiting
City of Hope Duarte California Recruiting
H. Lee Moffitt Cancer Center Tampa Florida Recruiting
City of Hope Chicago, City of Hope Cancer Center Chicago Zion Illinois Recruiting
Washington University St Louis Missouri Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas Recruiting

More Regeneron Pharmaceuticals trials in Egypt

A Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07594106 on ClinicalTrials.gov ↗ ← All trials in Egypt