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
NCT ID: NCT06413680
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
240 participants
INTERVENTIONAL
2024-09-23
2030-02-03
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1: Monotherapy Dose Escalation
Multiple Dose Level (DL) Cohorts to identify the Recommended Phase 2 Dose (RP2D)
REGN10597
Administered per the protocol
Phase 2: Monotherapy Dose Expansion
Cohort 1: Melanoma participants Cohort 2: Clear-cell Renal-Cell Carcinoma (ccRCC) participants
REGN10597
Administered per the protocol
Phase 1: Combination Dose Escalation
Multiple DL Cohorts to identify the RP2D
REGN10597
Administered per the protocol
Cemiplimab
Administered per the protocol
Phase 2: Combination Dose Expansion
Cohort 1: Melanoma participants
REGN10597
Administered per the protocol
Cemiplimab
Administered per the protocol
Interventions
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REGN10597
Administered per the protocol
Cemiplimab
Administered per the protocol
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of California San Francisco (UCSF)
San Francisco, California, United States
Yale School of Medicine
North Haven, Connecticut, United States
University of Chicago
Chicago, Illinois, United States
Start Midwest Cancer Research
Grand Rapids, Michigan, United States
Northwell Health
Lake Success, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Next Oncology
San Antonio, Texas, United States
The Start Center for Cancer Care
San Antonio, Texas, United States
Countries
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Central Contacts
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Related Links
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BrILliance
Other Identifiers
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2025-523399-22-00
Identifier Type: CTIS
Identifier Source: secondary_id
R10597-ONC-22114
Identifier Type: -
Identifier Source: org_study_id
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