Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma

Running, not enrolling · Phase 3

Conditions studied: Cholangiocarcinoma

In brief

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

Key facts

Study ID

NCT05948475

Run by

TransThera Sciences (Nanjing), Inc.

People needed

200

Starts

2023-12-20

Expected to finish

2026-12-01

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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.

You may not qualify if…

• 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.
• Concurrent anticancer therapy including chemo-, immune-, or radiotherapy. Hormone therapy may be allowed with Sponsor approval.
• Subjects who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting the study drug or who have not recovered from AEs of prior therapy.
• Subjects with uncontrolled hypertension (defined as blood pressure of ≥ 150 mm Hg systolic and/or ≥ 90 mm Hg diastolic despite adequate treatment with antihypertensive medications at screening)

Where it is running

• Stanford Cancer Center — Stanford, California, United States
• The University of Kansas Cancer Center — Westwood, Los Angeles, California, United States
• Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States
• The University of Chicago Hospitals — Chicago, Illinois, United States
• UMass Memorial Medical Center — Worcester, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford — Detroit, Michigan, United States
• University of Minnesota- Masonic Cancer Center, M Health Fairview — Minneapolis, Minnesota, United States
• Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States
• Messino Cancer Centers — Asheville, North Carolina, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Tennessee Oncology- Nashville — Nashville, Tennessee, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Texas Oncology-Sammons Cancer Center — Dallas, Texas, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• University of Virginia Cancer Center — Charlottesville, Virginia, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Ordensklinikum Linz GmbH — Linz, Austria
• Landesklinikum Wiener Neustadt — Wiener Neustadt, Austria
• Universitair Ziekenhuis Antwerpen — Antwerp, Belgium
• Universitair Ziekenhuis Gent — Ghent, Belgium
• Universitair Ziekenhuis Leuven — Leuven, Belgium
• Institut Sainte Catherine - Institut du Cancer Avignon Provence — Avignon, France
• UCLA Medical Center — Santa Monica, California, United States

Full record on ClinicalTrials.gov

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