This study is a Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician's Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma
≥ 18 years of age at the time of signing the informed consent form (ICF).
Histologically or cytologically confirmed CCA/adenocarcinoma of biliary origin with radiological evidence of unresectable or metastatic disease.
Documentation of FGFR2 fusion/rearrangement gene status
Subjects must have received at least one line of prior chemotherapy and exactly one FDA approved FGFR inhibitor.
Prior receipt of two or more FGFR inhibitors, either approved or investigational drugs.
Subjects with known brain or central nervous system (CNS) metastases that have radiologically or clinically progressed in the 28 days prior to initiation of therapy. Subjects with asymptomatic brain/CNS metastases or treated brain/CNS metastases that have been clinically stable for 14 days on steroids without escalation of steroids are eligible for enrollment.
Subjects with a known concurrent malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, including those that have previously undergone potentially curative therapy.
Subjects who have received prior systemic therapy or investigational study drug ≤ 5 half-lives or 14 days, whichever is shorter, prior to starting the study drug or who have not recovered (grade ≤ 1 or at pretreatment baseline except tolerable grade 2 alopecia, fatigue/asthenia, and neuropathy due to trauma) from adverse events (AEs) of prior therapy.
Parallel
Tinengotinib 8 mg
DrugSubjects randomized to receive tinengotinib will receive a starting dose of either 8 mg QD., self-administered orally QD in 28-day cycles.
Tinengotinib 10 mg
DrugSubjects randomized to receive tinengotinib will receive a starting dose of either10 mg QD., self-administered orally QD in 28-day cycles.
Physician's Choice
DrugFor subjects receiving FOLFOX or FOLFIRI, the subject will receive treatment every two weeks, with two administrations per each 28-day cycle.
Part A: Incidence, duration, and severity of adverse events (AEs)
As assessed per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (or the most current version).
Part B: PFS by BICR
Progression-free survival (PFS) by BICR: PFS is defined as the time from date of randomization to the date of first documented disease progression as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or date of death due to any cause, whichever is earlier.
Part A: ORR by Investigator
ORR:objective response rate (ORR), the proportion of subjects who achieved a complete response (CR) or a partial response (PR) based on RECIST version 1.1.
Part A: DOR by Investigator
Duration of response for CR or PR based on RECIST version 1.1.
Part B:Overall Survival (OS)
OS is defined as the time from date of randomization to date of death of any cause.
Part B: Objective Response Rate (ORR) by BICR and by Investigator:
The proportion of subjects who achieved a complete response (CR) or a partial response (PR) based on RECIST version 1.1.
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