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
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)
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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:
* 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 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, or discontinuation of prior anti-cancer immunotherapy 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.
Primary outcome measure(s)
Incidence of Dose-Limiting Toxicities (DLTs) — Up to Day 29 Dose escalation
Incidence of Treatment-Emergent Adverse Event (TEAEs) — Approximately 6 Years Dose escalation
Incidence of Serious Adverse Events (SAEs) — Approximately 6 Years Dose escalation
Incidence of TEAEs leading to treatment discontinuation — Approximately 6 Years Dose escalation
Incidence of TEAEs leading to death — Approximately 6 Years Dose escalation
Number of participants with Grade 3 laboratory abnormalities — Approximately 6 Years Dose escalation Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria by investigator assessment — Approximately 6 Years Dose expansion
Trial sites (11)
Facility
City
Region
Status
USC Norris Comprehensive Cancer Center
Los Angeles
California
Recruiting
University of California San Francisco (UCSF)
San Francisco
California
Recruiting
Yale School of Medicine
North Haven
Connecticut
Recruiting
University of Chicago
Chicago
Illinois
Recruiting
Start Midwest Cancer Research
Grand Rapids
Michigan
Recruiting
Northwell Health
Lake Success
New York
Recruiting
University of North Carolina at Chapel Hill
Chapel Hill
North Carolina
Recruiting
University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh
Pennsylvania
Recruiting
MD Anderson Cancer Center
Houston
Texas
Recruiting
Next Oncology
San Antonio
Texas
Recruiting
The Start Center for Cancer Care
San Antonio
Texas
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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