This is a multicenter, open-label, dose-escalation/dose-expansion Phase 1 clinical study to investigate the safety, tolerability, PK profile, pharmacodynamics, and preliminary clinical efficacy of INCB106385 when given as monotherapy or in combination with INCMGA00012 in participants with selected CD8 T-cell-positive advanced solid tumors including SCCHN, NSCLC, ovarian cancer, CRPC, TNBC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
INCB106385 will be administered orally QD
INCMGA0012 will be administered IV once every 4 weeks (Q4W)
Cedars-Sinai Medical Center
West Hollywood, California, United States
University of Maryland-Greenebaum Cancer Center
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Columbia University Medical Center
New York, New York, United States
Number of treatment-emergent adverse events (TEAE)
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 90 days after last dose of study drug.
Time frame: Up to Approximately 28 months
Cmax of INCB106385 as a single agent or in combination with INCMGA00012
Maximum observed plasma concentration.
Time frame: Up to 6 months
Tmax of INCB106385 as a single agent or in combination with INCMGA00012
Time to maximum plasma concentration
Time frame: Up to 6 months
Cmin of INCB106385 as a single agent or in combination with INCMGA00012
Minimum observed plasma concentration over the dose interval
Time frame: Up to 6 months
AUC of INCB106385 as a single agent or in combination with INCMGA00012
Area under the plasma concentration-time curve
Time frame: Up to 6 months
CL/F of INCB106385 as a single agent or in combination with INCMGA00012
Apparent oral dose clearance
Time frame: Up to 6 months
Objective Response Rate (ORR)
Defined as the percentage of participants with a best overall response of CR or PR, as determined by investigator radiographic disease assessment according to RECIST v1.1.
Time frame: Up to approximately 24 months
Disease Control Rate
Defined as the percentage of participants with a best overall response of CR, PR, or SD, as determined by investigator radiographic disease assessment according to RECIST v1.1.
Time frame: Up to approximately 24 months
Duration Of Response (DOR)
Defined as the time from the earliest date of CR or PR until the earliest date of disease progression, as determined by investigator radiographic disease assessment according to RECIST v1.1, or death due to any cause if occurring sooner than progression.
Time frame: Up to approximately 24 months
Change in tumoral gene expression
Defined as the percent of patients with change in tumoral targeted gene expression compared to baseline
Time frame: Predose and Week 5-6
Change in immune cell activation in tumors
Defined as the percent of patients demonstrating change in immune cell activation in tumors compared to baseline
Time frame: Predose and Week 5-6
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Md Anderson Cancer Center
Houston, Texas, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States
Cliniques Universitaires Ucl Saint-Luc
Brussels, Belgium
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven, Belgium
...and 17 more locations