Phase 1 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary antitumor activity of COM902 as monotherapy and in combination with COM701 in subjects with advanced malignancies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
COM902 monotherapy administered IV every 3 weeks in sequential dose escalation doses in cohorts of subjects.
Both study drugs will be evaluated at the RDFE for assessment of safety and tolerability. All study drugs will be administered IV every 3 weeks.
COM902 monotherapy (RDFE) in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.
COM902 in combination with COM701 (both at RDFE) in subjects with select tumor types who have exhausted standard treatment - HNSCC, CRC (MSS), NSCLC. All study drugs will be administered IV every 3 weeks.
Triplet combination of COM902 + COM701 + Pembrolizumab administered IV every 3 weeks.
Florida Cancer Specialists
Sarasota, Florida, United States
Massachusetts General Hospital.
Boston, Massachusetts, United States
START Midwest.
Grand Rapids, Michigan, United States
The Ohio State University Comprehensive Cancer Center.
Columbus, Ohio, United States
The University of Tennessee WEST Cancer Center.
Memphis, Tennessee, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
MD Anderson Cancer Center.
Houston, Texas, United States
The START Center for Cancer Care.
San Antonio, Texas, United States
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, United States
The safety and tolerability of COM902 monotherapy and in combination with COM701.
Incidence of subjects with Adverse Events (AEs) as per CTCAE v5.0 and Dose-Limiting Toxicities (DLTs).
Time frame: DLT evaluation window in the 1st cycle (21 Days).
To identify the maximum tolerated dose (MTD) and/or recommended dose for expansion of COM902 monotherapy and in combination with COM701.
Evaluation of a dose of COM902 monotherapy and in combination with COM701 that is well tolerated by subjects.
Time frame: 18 months.
To characterize the pharmacokinetic (PK) profile of COM902 as monotherapy and in combination with COM701.
Evaluation of parameters of COM902 monotherapy or in combination with COM701 exposure such as Maximum Plasma Concentration \[Cmax\]).
Time frame: 18 months.
Evaluation of safety and tolerability of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Incidence of subjects on the Triplet combination (COM902 + COM701 + Pembrolizumab) with Adverse Events (AEs) per CTCAE v5.0.
Time frame: 18 months.
Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Evaluation of PK parameters e.g., Cmax.
Time frame: 18 months.
Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Evaluation of PK parameters e.g., AUC.
Time frame: 18 months.
To characterize immunogenicity of COM902 monotherapy and in combination with COM701.
Evaluation of anti drug antibody to COM902 (monotherapy) or COM902, COM701 when administered in combination.
Time frame: 18 months.
To characterize the immunogenicity of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Evaluation of antidrug antibody to COM902, COM701.
Time frame: 18 months.
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