Study Comparing Tinengotinib to Doctor's Choice for Treating Cholangiocarcinoma with FGFR Changes

Sponsor: TransThera Sciences (Nanjing), Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05948475

Provider View

This clinical trial is testing the effectiveness and safety of the drug Tinengotinib compared to treatments chosen by doctors for patients with cholangiocarcinoma, a type of bile duct cancer, that has specific genetic changes and has not responded to previous treatments.

Patient Parameters

Program Overview

This study is a Phase III trial, meaning it is in the later stages of testing, to compare the effects of the oral drug Tinengotinib against treatments chosen by doctors for patients with cholangiocarcinoma. This cancer has specific changes in the FGFR gene and has not responded to previous chemotherapy and FGFR inhibitor treatments. The study will involve multiple centers around the world and aims to determine which treatment is more effective and safe.

Description

In this study, about 200 participants will be involved. They will be randomly assigned to different treatment groups. In Part A, participants will receive either 8 mg or 10 mg of Tinengotinib daily, or a treatment chosen by their doctor. In Part B, participants will receive the recommended dose of Tinengotinib or a treatment chosen by their doctor. The study aims to find out which treatment works best for patients with cholangiocarcinoma that has specific FGFR gene changes and has not responded to previous treatments.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of cholangiocarcinoma, a type of bile duct cancer, that cannot be removed by surgery or has spread to other parts of the body.
  • Have specific genetic changes in the FGFR2 gene.
  • Must have received at least one previous chemotherapy treatment and one FDA-approved FGFR inhibitor.

Exclusion Criteria

  • Have received two or more FGFR inhibitors in the past.
  • Have brain or central nervous system cancer that has worsened in the last 28 days. Patients with stable or symptom-free brain cancer can participate.
  • Have another type of cancer that is getting worse or needs treatment, except for certain non-invasive cancers like skin cancer or cervical cancer.
  • Have received other cancer treatments or experimental drugs recently and have not recovered from their side effects.
  • Are currently receiving other cancer treatments like chemotherapy, immunotherapy, or radiation, unless approved by the study sponsor.
  • Have uncontrolled high blood pressure despite treatment.

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