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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
NCT06413680 · Regeneron Pharmaceuticals
In plain English
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Official title
A Phase 1/2a, Open-Label, Dose Escalation and Dose Expansion First-In-Human Study of the Safety, Tolerability, Activity, and Pharmacokinetics of REGN10597 (Anti-PD-1-IL-2RA-IL-2 Fusion Protein) Alone or in Combination With Cemiplimab in Patients With Advanced Solid Organ Malignancies
About this study
Phase 1: Conducted in the United States only Phase 2: Conducted globally
Eligibility criteria
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
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
Key Exclusion Criteria:
1. 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
Enrollment target: 240 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-09-23
Estimated completion: 2030-02-03
Last updated: 2025-12-15
Interventions
Drug: REGN10597Drug: Cemiplimab
Primary outcomes
- • Incidence of Dose-Limiting Toxicities (DLTs) (Up to Day 29)
- • Incidence of Treatment-Emergent Adverse Event (TEAEs) (Approximately 6 Years)
- • Incidence of Serious Adverse Events (SAEs) (Approximately 6 Years)
Sponsor
Regeneron Pharmaceuticals · industry
Contacts & investigators
ContactClinical Trials Administrator · contact · clinicaltrials@regeneron.com · 844-734-6643
InvestigatorClinical Trial Management · study_director, Regeneron Pharmaceuticals
All locations (11)
USC Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
University of California San Francisco (UCSF)Recruiting
San Francisco, California, United States
Yale School of MedicineRecruiting
North Haven, Connecticut, United States
University of ChicagoRecruiting
Chicago, Illinois, United States
Start Midwest Cancer ResearchRecruiting
Grand Rapids, Michigan, United States
Northwell HealthRecruiting
Lake Success, New York, United States
University of North Carolina at Chapel HillRecruiting
Chapel Hill, North Carolina, United States
University of Pittsburgh Medical Center - Hillman Cancer CenterRecruiting
Pittsburgh, Pennsylvania, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Next OncologyRecruiting
San Antonio, Texas, United States
The Start Center for Cancer CareRecruiting
San Antonio, Texas, United States