This study is researching an experimental drug called REGN5093-M114 by itself and in combination with cemiplimab. The study is focused on advanced non-small cell lung cancer (NSCLC) that produces too much of a protein called mesenchymal epithelial transition factor (MET) on the cancer cell surface. The aim of the study is to see how safe, tolerable, and effective the study drug is. This study will include 3 study groups, or cohorts, and each group is split into 2 parts: Part 1: The main purpose of part 1 is to determine a safe dose of REGN5093-M114 (Cohorts A and B), and in combination with cemiplimab (Cohort C). Part 2: The main purpose of part 2 is to use the REGN5093-M114 dose found for each cohort in part 1 to see how well the study drug works to shrink tumors. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drug * Does the study drug work to reduce or delay the progression of your cancer * How much study drug is in the blood at different times * Does the body make antibodies against the study drug (which could make the drug less effective or could lead to side effects)
The trial was intended to be a Phase 1/2 trial, but no participants were enrolled in Phase 2
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Administered by intravenous (IV) infusion
Administered by IV infusion
University of California Irvine School of Medicine - Suite 400, Room 407
Orange, California, United States
University of Colorado Hospital Anshutz Outpatient Pavillion
Denver, Colorado, United States
Johns Hopkins Hospital - Clinical Study Location - Skip Viragh Outpatient Cancer Building
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center - 4F Second Medical Building
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Hospital, Henry Ford Cancer Institute
Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
MUSC Hollings Cancer Center
Charleston, South Carolina, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
...and 1 more locations
Dose limiting toxicities (DLTs)
Dose escalation (Phase 1)
Time frame: Up to 28 days
Treatment-emergent adverse events (TEAEs)
Dose escalation (Phase 1)
Time frame: Through study completion, an average of 2 years
Serious adverse events (SAEs)
Dose escalation (Phase 1)
Time frame: Through study completion, an average of 2 years
TEAEs leading to study treatment discontinuation
Dose escalation (Phase 1)
Time frame: Through study completion, an average of 2 years
TEAEs leading to death
Dose escalation (Phase 1)
Time frame: Through study completion, an average of 2 years
Laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE])
Dose escalation (Phase 1)
Time frame: Through study completion, an average of 2 years
Concentrations of REGN5093-M114 in serum
Dose escalation (Phase 1)
Time frame: Through study completion, an average of 2 years
Total monoclonal antibodies (REGN5093- M114 plus unconjugated antibody) in serum
Dose escalation (Phase 1)
Time frame: Through study completion, an average of 2 years
Concentrations of M24 in plasma
Dose escalation (Phase 1)
Time frame: Through study completion, an average of 2 years
Concentrations of cemiplimab when given in combination with REGN5093-M114
Dose escalation (Phase 1) Cohort C
Time frame: Through study completion, an average of 2 years
Objective response rate (ORR)
Dose expansion (Phase 2)
Time frame: Through study completion, an average of 2 years
ORR
Dose escalation (Phase 1)
Time frame: Through study completion, an average of 2 years
TEAEs
Dose expansion (Phase 2)
Time frame: Through study completion, an average of 2 years
SAEs
Dose expansion (Phase 2)
Time frame: Through study completion, an average of 2 years
TEAEs leading to study treatment discontinuation
Dose expansion (Phase 2)
Time frame: Through study completion, an average of 2 years
TEAEs leading to death
Dose expansion (Phase 2)
Time frame: Through study completion, an average of 2 years
Laboratory abnormalities (grade 3 or higher per CTCAE)
Dose expansion (Phase 2)
Time frame: Through study completion, an average of 2 years
Concentrations of REGN5093-M114 in serum
Dose expansion (Phase 2)
Time frame: Through study completion, an average of 2 years
Total monoclonal antibodies (REGN5093- M114 plus unconjugated antibody) in serum
Dose expansion (Phase 2)
Time frame: Through study completion, an average of 2 years
Concentrations of M24 in plasma
Dose expansion (Phase 2)
Time frame: Through study completion, an average of 2 years
Concentrations of cemiplimab when given in combination with REGN5093-M114
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Dose expansion (Phase 2) Cohort C
Time frame: Through study completion, an average of 2 years
Incidence of Anti-drug antibodies (ADA) against cemiplimab over time, when given in combination with REGN5093-M114
Dose expansion (Phase 2) Cohort C
Time frame: Through study completion, an average of 2 years
Titer of ADA against cemiplimab over time, when given in combination with REGN5093-M114
Dose expansion (Phase 2) Cohort C
Time frame: Through study completion, an average of 2 years
Duration of response (DOR)
Phase 1 and Phase 2
Time frame: Through study completion, an average of 2 years
Disease control rate (DCR)
Phase 1 and Phase 2
Time frame: Through study completion, an average of 2 years
Time to tumor response (TTR)
Phase 1 and Phase 2
Time frame: Through study completion, an average of 2 years
Progression free survival (PFS)
Phase 1 and Phase 2
Time frame: Through study completion, an average of 2 years
Overall survival (OS)
Phase 1 and Phase 2
Time frame: Through study completion, an average of 2 years
Incidence of ADA to REGN5093-M114 over time in monotherapy
Phase 1 and Phase 2
Time frame: Through study completion, an average of 2 years
Titer of ADA to REGN5093-M114 over time in monotherapy
Phase 1 and Phase 2
Time frame: Through study completion, an average of 2 years
Incidence of ADA to REGN5093-M114 over time in combination with cemiplimab
Phase 1 and Phase 2
Time frame: Through study completion, an average of 2 years
Titer of ADA to REGN5093-M114 over time in combination with cemiplimab
Phase 1 and Phase 2
Time frame: Through study completion, an average of 2 years