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Comparing Tinengotinib to Physician's Choice for Cholangiocarcinoma Treatment

A Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib VS Physician's Choice in Subjects With FGFR-altered, Chemotherapy- and FGFR Inhibitor-Cholangiocarcinoma

Phase 3 Interventional TransThera Sciences (Nanjing), Inc. · NCT05948475

This study is testing if a new oral medication called tinengotinib can help people with a tough type of bile duct cancer who haven't had success with other treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorTransThera Sciences (Nanjing), Inc. Industry-sponsored
Drugs / interventionschemotherapy, radiation, Tinengotinib
Locations87 sites (Santa Monica, California and 86 other locations)
Trial IDNCT05948475 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial evaluates the efficacy and safety of oral tinengotinib compared to physician's choice in patients with FGFR-altered, chemotherapy- and FGFR inhibitor-refractory cholangiocarcinoma. Approximately 200 subjects will be enrolled and randomized to receive either tinengotinib at two different doses or the physician's choice of treatment. The study aims to determine if tinengotinib can provide a better treatment option for patients who have not responded to previous therapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with FGFR2 alterations and refractory cholangiocarcinoma who have received prior chemotherapy and one FGFR inhibitor.

Not a fit: Patients who have received two or more FGFR inhibitors or have active brain metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with difficult-to-treat cholangiocarcinoma.

How similar studies have performed: Other studies have shown promise with FGFR inhibitors in cholangiocarcinoma, but the specific use of tinengotinib in this context is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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)

Where this trial is running

Santa Monica, California and 86 other locations

+37 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions CholangiocarcinomaRefractory/Relapsed Cholangiocarcinoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.