This is an open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4859 in adult participants with intrahepatic cholangiocarcinoma (iCCA) or other advanced solid tumors with FGFR2 and/or FGFR3 genetic alternations.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
CGT4859 is a selective FGFR2/3 inhibitor
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
RECRUITINGStanford Cancer Institute
Palo Alto, California, United States
RECRUITINGMayo Clinic Jacksonville
Jacksonville, Florida, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGUniversity of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGMayo Clinic Rochester
Rochester, Minnesota, United States
RECRUITINGThe Christ Hospital
Cincinnati, Ohio, United States
RECRUITINGTaussig Cancer Center - Cleveland Clinic
Cleveland, Ohio, United States
RECRUITINGFox Chase cancer Center
Philadelphia, Pennsylvania, United States
RECRUITING...and 5 more locations
Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - AEs
Incidence, severity, and seriousness or treatment-emergent adverse events (AEs) leading to dose modification
Time frame: Approximately 12 months
Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - Laboratory results
Clinically significant changes or abnormalities observed from baseline in laboratory results in chemistry, hematology, and coagulation parameters
Time frame: Approximately 12 months
Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - ECG results
Clinically significant changes or abnormalities observed from baseline in electrocardiogram (ECG) parameters
Time frame: Approximately 12 months
Phase 2: Evaluate antitumor activity of CGT4859 - Objective Response Rate (ORR)
Time frame: Approximately 8 months
Phase 1: Pharmacokinetics
Plasma concentration levels of CGT4859
Time frame: Approximately 28 days
Phase 1: Evaluate antitumor activity of CGT4859 - Objective Response Rate (ORR)
Time frame: Approximately 8 months
Phase 1 and Phase 2: Evaluate antitumor activity of CGT4859 - Disease Control Rate (DCR)
Time frame: Approximately 8 months
Phase 2: Characterize the safety of CGT4859 - AEs
Incidence, severity, and seriousness or treatment-emergent adverse events (AEs) leading to dose modification
Time frame: Approximately 9 months
Phase 2: Characterize the safety of CGT4859 - Labs, ECG
Changes from baseline in key laboratory results and electrocardiogram (ECG) parameters
Time frame: Approximately 9 months
Phase 2: Pharmacokinetics at RP2D
Plasma concentration levels of CGT4859
Time frame: Approximately 28 days
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