This study is an open-label, multicenter study to evaluate the efficacy and safety of TT-00420 tablet in adult patients with advanced cholangiocarcinoma.
This is a Phase II, open-label study to evaluate the efficacy and safety of TT00420 in patients with advanced/metastatic and surgically unresectable cholangiocarcinoma (CCA) with 1) FGFR 2 fusions who failed prior FGFR inhibitor treatment, 2) FGFR2 fusions who responded on prior FGFR inhibitor treatment, 3) with other FGFR alterations, or 4) whose tumors do not contain a detectable FGFR alteration.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
TT-00420 tablet, administered orally once daily
Objective Response Rate (ORR) in patients with FGFR2 fusions who have failed at least one previous treatment with an FGFR inhibitor (Cohort A1)
The proportion of subjects who achieved a complete response (CR) or a partial response (PR) based on RECIST version 1.1.
Time frame: Through study completion, an average of 9 months.
ORR in patients with FGFR2 fusions who have responded (CR or PR) on at least one previous treatment with an FGFR inhibitor and discontinued due to progressive disease (Cohort A2)
Time frame: Through study completion, an average of 9 months.
ORR in patients with FGFR alterations other than FGFR2 fusions (Cohort B)
Time frame: Through study completion, an average of 9 months.
ORR in patients without FGFR alterations (wild-type FGFR mutation status) (Cohort C)
Time frame: Through study completion, an average of 9 months.
ORR in all patients with FGFR alterations (Cohorts A and B)
Time frame: Through study completion, an average of 9 months.
Progression Free Survival (PFS) (All Cohorts)
Time frame: From first study drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Disease Control Rate (DCR) (All Cohorts)
Defined as CR + PR + stable disease (SD)
Time frame: Through study completion, an average of 9 months.
Overall Survival (OS) (All Cohorts)
Time frame: From first study drug administration until the date of death from any cause, assessed up to 24 months
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Providence Cancer Center
Anchorage, Alaska, United States
City of Hope
Duarte, California, United States
University of California, Los Angeles, School of Medicine
Santa Monica, California, United States
USO Oncology Network- Rocky Mountain Cancer Centers
Denver, Colorado, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
University of Chicago Medical Center - Duchossis Center for Advanced Medicine
Chicago, Illinois, United States
University of Maryland - Marlene and Stewart Greenebaum Cancer Center
Baltimore, Maryland, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Henry Ford Health Center
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
...and 22 more locations
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment (All Cohorts)
As assessed per CTCAE version 5.0
Time frame: Up to 30 days from study discontinuation
Concentration of TT-00420 at Protocol-Specified Timepoints (All Cohorts)
Time frame: From Cycle 1 to Cycle 4, an average of 4 months (each cycle is 28 days)