A First-In Human (FIH) Study to Find Out How Well REGN10597 Medicine Given Alone or in Combination With Cemiplimab Works in Adult Participants Who Have Cancer With Tumors That Have Spread in Their Body
Purpose
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: - What side effects may happen from taking the study drug(s) - How much study drug(s) is in the blood at different times - Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)
Conditions
- Melanoma
- Clear-Cell Renal-Cell Carcinoma (ccRCC)
- Advanced Solid Tumors
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 2. 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: - Module 1, Cohort 1: anti-PD-(L)1 Progressed Melanoma or - Module 1, Cohort 2: anti-PD-(L)1 Progressed RCC or - Module 2, Cohort 1: 1L Melanoma 2. ALL Participants ARE REQUIRED to submit fresh pretreatment biopsy during screening, with an additional exploratory biopsy at other time points
Exclusion Criteria
- Prior treatment with Interleukin 2 (IL2)/IL15/IL-7 given outside the context of concurrent administration with adoptive cell therapy 2. Prior treatment with anti-PD1/PD-L1, or an approved systemic therapy or any previous systemic non-immunomodulatory biologic therapy within 4 weeks, as defined in the protocol 3. Has received radiation therapy or major surgery within 14 days prior to first dose of study drug or has not yet recovered from AEs 4. Has had prior anti-cancer immunotherapy within 4 weeks prior to study intervention, and discontinuation due to grade 3 or 4 toxicities 5. Has ongoing immune-related AEs prior to initiation of study intervention, as defined in the protocol 6. Has known allergy or hypersensitivity to components of the study drug(s) 7. Has any condition requiring ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1-2 weeks to the first dose of study intervention 8. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease or any other condition that required treatment with systemic immunosuppressive treatments NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Phase 1: Monotherapy Dose Escalation |
Multiple Dose Level (DL) Cohorts to identify the Recommended Phase 2 Dose (RP2D) |
|
|
Experimental Phase 2: Monotherapy Dose Expansion |
Cohort 1: Melanoma participants Cohort 2: Clear-cell Renal-Cell Carcinoma (ccRCC) participants |
|
|
Experimental Phase 1: Combination Dose Escalation |
Multiple DL Cohorts to identify the RP2D |
|
|
Experimental Phase 2: Combination Dose Expansion |
Cohort 1: Melanoma participants |
|
Recruiting Locations
Los Angeles, California 90089
San Francisco, California 94143
North Haven, Connecticut 06473
Chicago, Illinois 60637
Grand Rapids, Michigan 49546
Lake Success, New York 11042
Chapel Hill, North Carolina 27514
Pittsburgh, Pennsylvania 15232
Houston, Texas 77030
San Antonio, Texas 78229
San Antonio, Texas 78229
More Details
- NCT ID
- NCT06413680
- Status
- Recruiting
- Sponsor
- Regeneron Pharmaceuticals
Detailed Description
Phase 1: Conducted in the United States only Phase 2: Conducted globally