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NCT Number: NCT07594106

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

Participants with mCRPC:

  • Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma
  • mCRPC with PSA value at screening ≥4 ng/mL and that has progressed within 6 months prior to screening as described in the protocol
  • Has received ≥2 lines of prior systemic therapy approved in the metastatic and/or castration-resistant setting as described in the protocol
  • 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:

  • Men and women with histologically or cytologically confirmed Renal Cell Carcinoma (RCC) with a clear-cell component
  • Diagnosis of metastatic ccRCC with at least 1 measurable lesion via Response evaluation criteria in solid tumors (RECIST) 1.1 criteria
  • 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:

  • 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:

  • 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

Treatment and study plan

REGN15505

Drug

Administered per protocol

REGN15505+Cemiplimab

Drug

Administered per protocol

Other names: REGN2810, Libtayo

REGN15505+REGN4336

Drug

Administered per protocol

Primary outcomes

  1. Occurrence of Dose Limiting Toxicities (DLTs)

    Time frame: Up to 5 years

    Dose Escalation

  2. Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to 5 years

    Dose Escalation

  3. Occurrence of Serious Adverse Events (SAEs)

    Time frame: Up to 5 years

    Dose Escalation

  4. Occurrence of Adverse Events of Special Interest (AESIs)

    Time frame: Up to 5 years

    Dose Escalation

  5. 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)

    Time frame: Up to 5 years

    Dose Expansion-mCRPC

  6. Objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Time frame: Up to 5 years

    Dose Expansion-ccRCC

Secondary outcomes

  1. Occurrence of TEAEs

    Time frame: Up to 5 years

    Dose Expansion

  2. Occurrence of SAEs

    Time frame: Up to 5 years

    Dose Expansion

  3. Occurrence of AESIs

    Time frame: Up to 5 years

    Dose Expansion

  4. CompR based on ≥50% decline of PSA from baseline and/or confirmed radiographic assessment of CR or PR

    Time frame: Up to 5 years

    Dose Escalation-mCRPC

  5. Percentage of participants with ≥50% reduction of PSA

    Time frame: Up to 5 years

    Dose Escalation and Dose Expansion Phases - mCRPC cohorts

  6. Percentage of participants with ≥90% reduction in PSA

    Time frame: Up to 5 years

    Dose Escalation and Dose Expansion - mCRPC cohorts

  7. Concentration of REGN15505 in serum

    Time frame: Up to 5 years

    Dose Escalation and Expansion

  8. Occurrence of Anti Drug Antibodies (ADA) against REGN15505

    Time frame: Up to 5 years

    Dose Escalation and Expansion

  9. Occurrence of ADA against REGN4336

    Time frame: Up to 5 years

    Dose Escalation and Expansion

  10. Magnitude of ADA against REGN15505

    Time frame: Up to 5 years

    Dose Escalation and Expansion

  11. Magnitude of ADA against REGN4336

    Time frame: Up to 5 years

    Dose Escalation and Expansion

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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