Comparing Tinengotinib to Physician's Choice for Cholangiocarcinoma Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UCLA Medical Center
  Santa Monica, California, United States Recruiting
• Stanford Cancer Center
  Stanford, California, United States Recruiting
• The University of Kansas Cancer Center
  Westwood, Los Angeles, California, United States Recruiting
• Mount Sinai Comprehensive Cancer Center
  Miami Beach, Florida, United States Recruiting
• The University of Chicago Hospitals
  Chicago, Illinois, United States Recruiting
• Roswell Park Comprehensive Cancer Center
  Buffalo, New York, United States Recruiting

+37 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Milind Javle, MD — M.D. Anderson Cancer Center
• Study coordinator: Jean Fan, MD
• Email: fan_jean@transtherabio.com
• Phone: 86-25-86901107

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.