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 5368361, California 5332921 90089
San Francisco 5391959, California 5332921 94143
North Haven 4839704, Connecticut 4831725 06473
Chicago 4887398, Illinois 4896861 60637
Grand Rapids 4994358, Michigan 5001836 49546
Lake Success 5123853, New York 5128638 11042
Chapel Hill 4460162, North Carolina 4482348 27514
Pittsburgh 5206379, Pennsylvania 6254927 15232
Houston 4699066, Texas 4736286 77030
San Antonio 4726206, Texas 4736286 78229
San Antonio 4726206, Texas 4736286 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