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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523399-22-00 | EU Trial (CTIS) Number |
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This study is researching an experimental drug called REGN10597 alone or in combination with another drug called cemiplimab (called "study drug(s)"). The study is focused on patients with certain solid tumors that are in an advanced stage.
The aim of the study is to see how safe, tolerable, and effective the study drug(s) are.
The study is looking at several other research questions, including:
Phase 1: Conducted in the United States only Phase 2: Conducted globally
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: Monotherapy Dose Escalation | Experimental | Multiple Dose Level (DL) Cohorts to identify the Recommended Phase 2 Dose (RP2D) |
|
| Phase 2: Monotherapy Dose Expansion | Experimental | Cohort 1: Melanoma participants Cohort 2: Clear-cell Renal-Cell Carcinoma (ccRCC) participants |
|
| Phase 1: Combination Dose Escalation | Experimental | Multiple DL Cohorts to identify the RP2D |
|
| Phase 2: Combination Dose Expansion | Experimental | Cohort 1: Melanoma participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN10597 | Drug | Administered per the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose-Limiting Toxicities (DLTs) | Dose escalation | Up to Day 29 |
| Incidence of Treatment-Emergent Adverse Event (TEAEs) | Dose escalation | Approximately 6 Years |
| Incidence of Serious Adverse Events (SAEs) | Dose escalation | Approximately 6 Years |
| Incidence of TEAEs leading to treatment discontinuation | Dose escalation | Approximately 6 Years |
| Incidence of TEAEs leading to death | Dose escalation | Approximately 6 Years |
| Number of participants with Grade 3 laboratory abnormalities | Dose escalation Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | Approximately 6 Years |
| Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria by investigator assessment | Dose expansion | Approximately 6 Years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR based on RECIST 1.1 criteria by investigator assessment | Dose escalation | Approximately 6 Years |
| Best Overall Response (BOR) based on RECIST 1.1 criteria | Approximately 6 Years |
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Key Inclusion Criteria:
Dose escalation cohorts:
1. Histologically or cytologically confirmed diagnosis of solid malignancy (locally advanced or metastatic) with confirmed progression on standard-of-care therapy. Participants are required to submit archival tissue if it is available
Dose expansion cohorts:
1. Histologically of cytologically confirmed diagnosis of one of the following tumors with criteria, as defined in the protocol:
Key Exclusion Criteria:
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 |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Recruiting | Los Angeles | California | 90089 | United States | |
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| Label | URL |
|---|---|
| BrILliance | View source |
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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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| Cemiplimab | Drug | Administered per the protocol |
|
| Duration Of Response (DOR) based on RECIST 1.1 criteria | Approximately 6 Years |
| Disease control rate based on RECIST 1.1 | Approximately 6 Years |
| Time to response based on RECIST 1.1 | Approximately 6 Years |
| Progression Free Survival (PFS) based on RECIST 1.1 | Approximately 6 Years |
| Concentrations of REGN10597 in serum | Approximately 6 Years |
| Incidence of Anti-Drug Antibody (ADA) to REGN10597 over time | Approximately 6 Years |
| Magnitude of ADA to REGN10597 over time | Approximately 6 Years |
| University of California San Francisco (UCSF) |
| Recruiting |
| San Francisco |
| California |
| 94143 |
| United States |
| Yale School of Medicine | Recruiting | North Haven | Connecticut | 06473 | United States |
| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
| Start Midwest Cancer Research | Recruiting | Grand Rapids | Michigan | 49546 | United States |
| Northwell Health | Recruiting | Lake Success | New York | 11042 | United States |
| University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
| University of Pittsburgh Medical Center - Hillman Cancer Center | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| Next Oncology | Recruiting | San Antonio | Texas | 78229 | United States |
| The Start Center for Cancer Care | Recruiting | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D002292 | Carcinoma, Renal Cell |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000627974 | cemiplimab |
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