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)
Phase 1: Conducted in the United States only Phase 2: Conducted globally
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
Administered per the protocol
Administered per the protocol
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGUniversity of California San Francisco (UCSF)
San Francisco, California, United States
RECRUITINGYale School of Medicine
North Haven, Connecticut, United States
RECRUITINGUniversity of Chicago
Chicago, Illinois, United States
RECRUITINGStart Midwest Cancer Research
Grand Rapids, Michigan, United States
RECRUITINGNorthwell Health
Lake Success, New York, United States
RECRUITINGUniversity of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
RECRUITINGUniversity of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGNext Oncology
San Antonio, Texas, United States
RECRUITING...and 1 more locations
Incidence of Dose-Limiting Toxicities (DLTs)
Dose escalation
Time frame: Up to Day 29
Incidence of Treatment-Emergent Adverse Event (TEAEs)
Dose escalation
Time frame: Approximately 6 Years
Incidence of Serious Adverse Events (SAEs)
Dose escalation
Time frame: Approximately 6 Years
Incidence of TEAEs leading to treatment discontinuation
Dose escalation
Time frame: Approximately 6 Years
Incidence of TEAEs leading to death
Dose escalation
Time frame: Approximately 6 Years
Number of participants with Grade 3 laboratory abnormalities
Dose escalation Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: Approximately 6 Years
Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria by investigator assessment
Dose expansion
Time frame: Approximately 6 Years
ORR based on RECIST 1.1 criteria by investigator assessment
Dose escalation
Time frame: Approximately 6 Years
Best Overall Response (BOR) based on RECIST 1.1 criteria
Time frame: Approximately 6 Years
Duration Of Response (DOR) based on RECIST 1.1 criteria
Time frame: Approximately 6 Years
Disease control rate based on RECIST 1.1
Time frame: Approximately 6 Years
Time to response based on RECIST 1.1
Time frame: Approximately 6 Years
Progression Free Survival (PFS) based on RECIST 1.1
Time frame: Approximately 6 Years
Concentrations of REGN10597 in serum
Time frame: Approximately 6 Years
Incidence of Anti-Drug Antibody (ADA) to REGN10597 over time
Time frame: Approximately 6 Years
Magnitude of ADA to REGN10597 over time
Time frame: Approximately 6 Years
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