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Study on the Effectiveness and Safety of Tinengotinib for Patients with Cholangiocarcinoma Resistant to Chemotherapy and FGFR Inhibitors

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called cholangiocarcinoma, which affects the bile ducts. The study is testing a new treatment called tinengotinib, which is taken as a tablet. Tinengotinib is being compared to other treatments chosen by doctors for patients whose cancer has specific changes in the Fibroblast Growth Factor Receptor (FGFR) and who have not responded to previous chemotherapy or FGFR inhibitor treatments.

The purpose of the study is to evaluate how effective and safe tinengotinib is for these patients. Participants will receive either tinengotinib or another treatment selected by their doctor. The study will monitor the participants over a period to see how the cancer responds to the treatment and to check for any side effects. The study will also look at how long the participants live without the cancer getting worse.

In addition to tinengotinib, the study involves other medications that may be used as part of the doctor's choice, including folinic acid, irinotecan, fluorouracil, and oxaliplatin. These medications are given through injections or infusions. The study aims to provide more information on the best treatment options for patients with this type of cancer.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be informed about the trial's objectives and procedures. The patient must provide informed consent, confirming understanding and agreement to participate.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes verifying the diagnosis of cholangiocarcinoma, a type of cancer affecting the bile ducts, and checking for specific genetic markers related to the FGFR2 gene.

    The patient's overall health and organ function will be evaluated to ensure they meet the study's requirements.

  3. Step 3

    Treatment phase part A

    In Part A of the treatment phase, the patient will receive tinengotinib orally. The dosage will be either 8 mg or 10 mg once daily. The purpose is to assess the safety and tolerability of the medication.

    The patient will be monitored for any side effects or adverse reactions during this period.

  4. Step 4

    Treatment phase part B

    In Part B, the patient will continue with the selected dose of tinengotinib based on the results from Part A. The focus will be on evaluating the effectiveness of the treatment in controlling the disease.

    The patient's progress will be compared to other treatment options chosen by the physician.

  5. Step 5

    Additional treatments

    Depending on the treatment plan, the patient may receive additional medications such as folinic acid, irinotecan hydrochloride trihydrate, fluorouracil, and oxaliplatin. These are administered intravenously and are part of the standard chemotherapy regimen.

    The frequency and duration of these treatments will be determined by the study protocol and the patient's response.

  6. Step 6

    Monitoring and follow-up

    Throughout the trial, the patient will undergo regular monitoring to assess the treatment's impact on the disease and overall health. This includes imaging tests and blood tests.

    The patient will also be asked to report any side effects or changes in symptoms.

  7. Step 7

    End of treatment

    At the end of the treatment period, the patient's response to the therapy will be evaluated. This includes measuring progression-free survival, which is the time during and after treatment that the patient lives with the disease without it getting worse.

    The patient will receive guidance on the next steps, which may include further treatment or follow-up care.

Who can join the trial?

10 criteria

  • Must be **18 years or older** at the time of signing the informed consent form.
  • Must be able to understand and sign the informed consent form and follow the study rules.
  • Must have a confirmed diagnosis of **cholangiocarcinoma** or adenocarcinoma of the bile ducts, with evidence that the disease cannot be surgically removed or has spread to other parts of the body.
  • Must have documentation showing a specific change in the **FGFR2 gene**.
  • Must have received at least one previous chemotherapy treatment and exactly one FGFR inhibitor approved by the FDA.
  • Must have a disease that can be measured by imaging tests like **CT** or **MRI**. This means having at least one tumor that is a certain size, and it should not be in an area that was previously treated with radiation unless it is a new tumor or shows signs of growth after radiation.
  • Must agree to have blood taken for a special test called a **liquid biopsy** to look at genes.
  • Must have a performance status of 0 to 1 on the **ECOG scale**, which measures how well a person can perform daily activities.
  • Must have adequate organ function, which will be checked through various blood tests. These tests include checking the number of certain blood cells, liver enzymes, bilirubin levels, kidney function, and blood clotting ability.
  • Must agree to use effective birth control methods to prevent pregnancy during the study and for at least 3 months after the study ends. This applies to both male and female participants unless they are surgically sterile or have not had a menstrual period for 12 months or more.

Who cannot join the trial?

8 criteria

  • Patients who have not been diagnosed with cholangiocarcinoma, which is a type of cancer that forms in the bile ducts.
  • Patients who do not have changes in their FGFR genes. FGFR stands for Fibroblast Growth Factor Receptor, which is a type of protein that can be involved in cancer growth.
  • Patients who have not previously been treated with chemotherapy or FGFR inhibitors and have not had their cancer return or resist these treatments.
  • Patients who are not within the specified age range for the study.
  • Patients who are not willing or able to follow the study procedures and requirements.
  • Patients who have other medical conditions that might interfere with the study or make participation unsafe.
  • Patients who are pregnant or breastfeeding.
  • Patients who are part of a vulnerable population that requires special protection.
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Investigated drugs

  • Tinengotinib

    is an oral medication being studied for its potential to treat cholangiocarcinoma, a type of cancer that affects the bile ducts. This medication is specifically being tested in patients whose cancer has certain changes in the fibroblast growth factor receptor (FGFR) and who have not responded to previous chemotherapy or FGFR inhibitor treatments. The study aims to determine how safe and effective tinengotinib is for these patients.

  • Physician's Choice

    refers to the standard treatment options that a doctor might choose for a patient with cholangiocarcinoma, based on the patient's specific condition and medical history. This could include a variety of treatments that are already approved and commonly used for this type of cancer. The study compares the effects of tinengotinib to these standard treatment options to see which is more effective.

What is already known about the treatment

Tinengotinib – Tinengotinib is an oral medication currently being studied in clinical trials for its effectiveness in treating cholangiocarcinoma, a type of bile duct cancer. It is administered in tablet form and taken once daily. The drug is in the investigational stage, with ongoing research to determine its safety and efficacy. Tinengotinib works by targeting and inhibiting the fibroblast growth factor receptor (FGFR), which plays a role in cancer cell growth and survival. It is classified as a targeted therapy, specifically an FGFR inhibitor, and is being evaluated for patients who have not responded to chemotherapy or other FGFR inhibitors.

Investigated diseases

Cholangiocarcinoma – Cholangiocarcinoma is a type of cancer that forms in the bile ducts, which are the tubes that carry bile from the liver to the gallbladder and small intestine. It is characterized by the abnormal growth of cells in the bile duct lining, leading to blockages and impaired bile flow. As the disease progresses, it can cause symptoms such as jaundice, abdominal pain, and weight loss. The cancer can spread to nearby tissues and organs, complicating the condition. It is often diagnosed at an advanced stage due to its subtle early symptoms. The progression of cholangiocarcinoma can vary, with some cases advancing more rapidly than others.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505660-11-00Protocol codeTT420C2308Estimated enrolment230 patientsSponsorTransthera Sciences (Nanjing) Inc.

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