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Clinical Trials in the UK / NCT05948475
Active, not recruiting Phase 3

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

NCT05948475 · tracked via the Priya Life Science UK tracker
Sponsor
TransThera Sciences (Nanjing), Inc.
Phase
Phase 3
Started
2023-12-20
Last updated
2026-07-06

Condition(s) studied

Cholangiocarcinoma

Investigational drug(s) / intervention(s)

Tinengotinib 8 mgTinengotinib 10 mgPhysician's Choice

Tinengotinib 8 mg: Subjects 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: Subjects randomized to receive tinengotinib will receive a starting dose of either10 mg QD., self-administered orally QD in 28-day cycles.

Physician's Choice: For subjects receiving FOLFOX or FOLFIRI, the subject will receive treatment every two weeks, with two administrations per each 28-day cycle.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. Histologically or cytologically confirmed CCA/adenocarcinoma of biliary origin with radiological evidence of unresectable or metastatic disease. 3. Documentation of FGFR2 fusion/rearrangement gene status 4. Subjects must have received at least one line of prior chemotherapy and exactly one FDA approved FGFR inhibitor. Exclusion Criteria: 1. Prior receipt of two or more FGFR inhibitors, either approved or investigational drugs. 2. 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. 3. 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. 4. 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. 5. Concurrent anticancer therapy including chemo-, immune-, or radiotherapy. Hormone therapy may be allowed with Sponsor approval. 6. 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. 7. 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)

Primary outcome measure(s)

Trial sites (87)

FacilityCityRegionStatus
UCLA Medical Center Santa Monica California
Stanford Cancer Center Stanford California
The University of Kansas Cancer Center Westwood, Los Angeles California
Mount Sinai Comprehensive Cancer Center Miami Beach Florida
The University of Chicago Hospitals Chicago Illinois
UMass Memorial Medical Center Worcester Massachusetts
University of Michigan Ann Arbor Michigan
Henry Ford Detroit Michigan
University of Minnesota- Masonic Cancer Center, M Health Fairview Minneapolis Minnesota
Roswell Park Comprehensive Cancer Center Buffalo New York
Messino Cancer Centers Asheville North Carolina
University Hospitals Cleveland Medical Center Cleveland Ohio
Tennessee Oncology- Nashville Nashville Tennessee
Vanderbilt-Ingram Cancer Center Nashville Tennessee
University of Texas Southwestern Medical Center Dallas Texas
Texas Oncology-Sammons Cancer Center Dallas Texas
The University of Texas MD Anderson Cancer Center Houston Texas
University of Virginia Cancer Center Charlottesville Virginia
Medical College of Wisconsin Milwaukee Wisconsin
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
Centre Hospitalier Régional Universitaire de Besançon Besançon France
Hopital Beaujon Clichy France
Hopital Franco-Britannique - Fondation Cognacq-Jay Levallois-Perret France
Clinique de la Sauvegarde Lyon France
Centre Hospitalier Universitaire de Montpellier Montpellier France
Hopital Saint Antoine Paris France
Institut de Cancerologie Gustave Roussy Villejuif France
Krebszentrum Reutlingen Baden Germany
Krankenhaus Nordwest gGmbH Frankfurt Germany
Asklepios Klinik Altona Hamburg Germany
Medizinische Hochschule Hannover Hanover Germany
Universitaetsklinikum Heidelberg (UKHD) - Nationales Centrum fuer Tumorerkrankungen Heidelberg (NCT) Heidelberg Germany
Ludwig-Maximilians-Universität München Kum München Germany
Clinica Oncologica, Ospedali Riuniti Umberto 1 Ancona Italy
Candiolo Cancer Institute - FPO IRCCS Candiolo Italy

+ 47 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05948475 on ClinicalTrials.gov ↗ ← All trials in the UK