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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Module 1: Monotherapy | Experimental | REGN15505 |
|
| Module 2: Combination 1 | Experimental | REGN15505 and Cemiplimab |
|
| Module 3: Combination 2 | Experimental | REGN15505 and REGN4336 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN15505 | Drug | Administered per protocol |
| |
| REGN15505+Cemiplimab |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Dose Limiting Toxicities (DLTs) | Dose Escalation | Up to 5 years |
| Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Dose Escalation | Up to 5 years |
| Occurrence of Serious Adverse Events (SAEs) | Dose Escalation | Up to 5 years |
| Occurrence of Adverse Events of Special Interest (AESIs) | Dose Escalation | Up to 5 years |
| 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) | Dose Expansion-mCRPC | Up to 5 years |
| Objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | Dose Expansion-ccRCC | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of TEAEs | Dose Expansion | Up to 5 years |
| Occurrence of SAEs | Dose Expansion | Up to 5 years |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
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All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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| Drug |
Administered per protocol |
|
|
| REGN15505+REGN4336 | Drug | Administered per protocol |
|
| Occurrence of AESIs | Dose Expansion | Up to 5 years |
| CompR based on ≥50% decline of PSA from baseline and/or confirmed radiographic assessment of CR or PR | Dose Escalation-mCRPC | Up to 5 years |
| Percentage of participants with ≥50% reduction of PSA | Dose Escalation and Dose Expansion Phases - mCRPC cohorts | Up to 5 years |
| Percentage of participants with ≥90% reduction in PSA | Dose Escalation and Dose Expansion - mCRPC cohorts | Up to 5 years |
| Concentration of REGN15505 in serum | Dose Escalation and Expansion | Up to 5 years |
| Occurrence of Anti Drug Antibodies (ADA) against REGN15505 | Dose Escalation and Expansion | Up to 5 years |
| Occurrence of ADA against REGN4336 | Dose Escalation and Expansion | Up to 5 years |
| Magnitude of ADA against REGN15505 | Dose Escalation and Expansion | Up to 5 years |
| Magnitude of ADA against REGN4336 | Dose Escalation and Expansion | Up to 5 years |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C000627974 | cemiplimab |
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