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Study on Repotrectinib for Patients with Advanced Solid Tumors with ALK, ROS1, or NTRK1-3 Gene Changes

Fast replyInvestigationalNo placebo
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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 the effects of a new treatment called Repotrectinib (TPX-0005) for patients with advanced solid tumors. These are types of cancer that have spread and are difficult to treat. The study is particularly interested in tumors that have specific changes in their genes, known as ALK, ROS1, or NTRK1-3 rearrangements. These gene changes can affect how cancer grows and responds to treatment.

The purpose of the study is to understand how safe and effective Repotrectinib is for treating these types of tumors. The study will involve taking the medication in the form of a hard capsule by mouth. Participants will be monitored to see how their tumors respond to the treatment and to check for any side effects. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment.

The study will be conducted in multiple phases, starting with a small group of participants to assess safety and then expanding to include more participants to evaluate how well the treatment works. The trial will continue over several years to gather comprehensive data on the treatment's effectiveness and safety. Participants will be grouped based on their specific type of tumor and previous treatments they have received. This study aims to provide new insights into treating advanced solid tumors with specific genetic changes.

The research process

The trial runs in 5 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 assigned to one of six expansion cohorts based on their specific gene rearrangement and previous treatments. These cohorts are designed to evaluate the effectiveness of the medication repotrectinib in patients with advanced solid tumors.

  2. Step 2

    Medication administration

    The patient will receive repotrectinib, which is administered orally in the form of hard capsules. The dosage and frequency will be determined by the study protocol and the patient's specific cohort assignment.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient's response to the medication will be closely monitored. This includes regular assessments to measure the size of the tumor and any changes in the patient's condition.

    The primary goal is to determine the Objective Response Rate (ORR), which is the proportion of patients whose tumors shrink or disappear after treatment.

  4. Step 4

    Evaluation of secondary outcomes

    Secondary outcomes will also be evaluated, including the Duration of Response (DOR), Time to Response (TTR), and Overall Survival (OS). These measures help to understand the long-term effects of the treatment.

  5. Step 5

    Completion of the study

    The study is expected to continue until February 2028. Upon completion, the data collected will be analyzed to determine the overall effectiveness and safety of repotrectinib in treating advanced solid tumors.

Who can join the trial?

12 criteria

  • The patient must have a confirmed diagnosis of a locally advanced or metastatic solid tumor. This includes tumors that have spread to other parts of the body or are in a stage where surgery or other treatments are not an option.
  • The tumor must have a specific change in its genes, known as a **ROS1** or **NTRK1-3 gene fusion**. This means that parts of these genes have joined together in a way that is not normal.
  • The patient must have a test result showing this gene fusion. The test can be done using special methods like **next-generation sequencing (NGS)**, **quantitative polymerase chain reaction (qPCR)**, or **fluorescence in situ hybridization (FISH)**. These are advanced tests that look at the genes in detail.
  • The patient must have at least one tumor that can be measured using a specific method called **RECIST**. This is a way to measure how big the tumor is and if it changes over time.
  • The patient will be placed into one of six groups based on their previous treatments and the type of gene fusion they have:
  • Group 1: Patients with **ROS1+ NSCLC** who have not had a specific type of treatment called **ROS1 TKI** before. They can have had one previous treatment with chemotherapy or immunotherapy.
  • Group 2: Patients with **ROS1+ NSCLC** who have had one **ROS1 TKI** and one chemotherapy treatment. They must have had a specific type of chemotherapy called **platinum-based chemotherapy**.
  • Group 3: Patients with **ROS1+ NSCLC** who have had two **ROS1 TKI** treatments but no chemotherapy or immunotherapy.
  • Group 4: Patients with **ROS1+ NSCLC** who have had one **ROS1 TKI** treatment but no chemotherapy or immunotherapy.
  • Group 5: Patients with **NTRK+ solid tumors** who have not had a specific type of treatment called **TRK TKI** before. They can have had any number of chemotherapy or immunotherapy treatments. Patients with **NSCLC** are not allowed in this group.
  • Group 6: Patients with **NTRK+ solid tumors** who have had one or two **TRK TKI** treatments. They can have had any number of chemotherapy or immunotherapy treatments. Patients with **NSCLC** are not allowed in this group.
  • The study is open to male patients only.

Who cannot join the trial?

4 criteria

  • Patients with medical conditions other than advanced solid tumors cannot participate. Advanced solid tumors are a type of cancer that has spread to other parts of the body.
  • Patients who do not have a specific gene change called ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement are excluded. These are specific changes in the genes that can affect how cancer grows.
  • Only male patients are eligible, so female patients cannot participate.
  • Patients who are considered part of a vulnerable population are excluded. This means people who might need special protection or care.
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Investigated drugs

Repotrectinib is a medication being studied for its potential to treat advanced solid tumors. These tumors have specific genetic changes known as ALK, ROS1, or NTRK1-3 rearrangements. The study aims to evaluate how safe and tolerable this medication is for patients, as well as how it behaves in the body and its ability to fight tumors.

What is already known about the treatment

Repotrectinib – Repotrectinib is administered orally and is currently being studied in clinical trials for its safety, tolerability, and effectiveness in treating advanced solid tumors with specific genetic rearrangements. It is in the investigational stage and not yet approved for general medical use. The main therapeutic indication is for tumors with ALK, ROS1, or NTRK1-3 rearrangements. At the molecular level, repotrectinib works by inhibiting the activity of certain proteins that promote cancer cell growth, specifically targeting the ALK, ROS1, and NTRK gene fusions. It is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

Advanced Solid Tumors – Advanced solid tumors are a group of cancers that originate in solid organs or tissues, such as the breast, lung, or colon, and have progressed to a more severe stage. These tumors are characterized by their ability to grow uncontrollably and invade nearby tissues. As they advance, they may spread to other parts of the body, a process known as metastasis. The progression of these tumors can vary depending on the type of cancer and its location. They often lead to the formation of masses or lumps that can be detected through imaging or physical examination. The behavior and growth rate of advanced solid tumors can differ significantly, influencing the symptoms experienced by the patient.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-512606-25-00Protocol codeTPX-0005-01Estimated enrolment627 patientsSponsorTurning Point Therapeutics Inc.

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