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Study of Entrectinib for Patients with Advanced or Metastatic Solid Tumors with Specific Gene Changes

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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 medication called entrectinib, also known by its code name RO7102122. The study is designed for patients with certain types of advanced or spreading solid tumors. These tumors have specific changes in their genes, known as NTRK1/2/3, ROS1, or ALK gene rearrangements. These gene changes can lead to the growth of cancer cells, and the study aims to see how well entrectinib can target and treat these tumors.

The purpose of the study is to determine how well entrectinib works in treating these specific types of tumors. Participants in the study will take entrectinib in the form of hard capsules, which are taken by mouth. The study will observe how the tumors respond to the treatment over time. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of entrectinib. The study will also monitor the safety of the medication and any side effects that may occur.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the progress of their tumors. The study will collect information on how long the response to the treatment lasts, the time it takes for the treatment to start working, and the overall survival of the participants. Additionally, the study will look at how the treatment affects the quality of life and health status of the participants. This research aims to provide valuable insights into the effectiveness of entrectinib for treating these specific genetic changes in tumors.

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, a diagnosis of a locally advanced or metastatic solid tumor with specific gene rearrangements is confirmed. This includes NTRK1/2/3, ROS1, or ALK gene rearrangements.

    Eligibility is determined based on the ability to swallow the medication, adequate liver function, and other health criteria.

  2. Step 2

    Medication administration

    The medication used in this study is Rozlytrek, which contains the active substance entrectinib. It is administered in the form of 200 mg hard capsules.

    The capsules are taken orally, and it is important to swallow them whole without chewing, crushing, or opening them.

  3. Step 3

    Treatment schedule

    The treatment involves taking the medication as prescribed by the study protocol. The specific dosage and frequency will be provided by the study team.

    The duration of the treatment will continue as long as it is deemed beneficial and safe, or until the study concludes.

  4. Step 4

    Monitoring and assessments

    Regular assessments will be conducted to monitor the response to the treatment. This includes measuring the size of the tumor and checking for any changes.

    Additional tests may include imaging studies and laboratory tests to evaluate overall health and the effect of the medication.

  5. Step 5

    End of study participation

    Participation in the study will end either when the treatment is no longer effective, if there are significant side effects, or when the study reaches its conclusion.

    Upon completion, a final assessment will be conducted to evaluate the overall response to the treatment.

Who can join the trial?

13 criteria

  • Must have a confirmed diagnosis of a **locally advanced or metastatic solid tumor** with specific gene changes (NTRK1/2/3, ROS1, or ALK) that can lead to a certain type of protein. This must be determined by specific testing methods. Patients should not have other major cancer-driving genes and should not have other effective treatment options available.
  • Must have an **ECOG performance status** of 2 or less, which means the patient should be able to carry out all self-care but unable to carry out any work activities. Must have a life expectancy of at least 4 weeks.
  • Must have **adequate liver function**, meaning certain liver enzymes and bilirubin levels should be within specified limits.
  • Women who can have children must have a negative pregnancy test, not be breastfeeding, and agree to use effective birth control methods during the study and for a period after the study. Men with partners who can have children must also use effective birth control and agree not to donate sperm during and after the study.
  • Must be able to swallow the study medication whole without altering the capsules.
  • For those tested locally, a sample of the tumor tissue must be submitted for further testing unless it's not medically possible.
  • Must have a **measurable disease** as determined by specific criteria. Patients with non-measurable disease can still participate but will mainly help assess safety and other study aspects.
  • Patients with **CNS involvement** (cancer spread to the brain or spinal cord) that is controlled or not causing symptoms can participate. Certain medications for seizures are allowed.
  • Previous cancer treatments are allowed, except for specific inhibitors if the tumor has certain gene changes. The study is not enrolling new patients for the ALK group.
  • Must wait at least 2 weeks or 5 half-lives (whichever is shorter) after previous chemotherapy or targeted therapy before starting the study medication. There should be no worsening of the disease after stopping previous targeted therapies.
  • Must wait at least 4 weeks after finishing antibody-based therapy before starting the study medication.
  • Previous **radiotherapy** is allowed if it ended more than 14 days before starting the study medication. For brain radiation, whole brain treatment must be completed at least 14 days prior, and specific targeted brain treatment at least 7 days prior.
  • Must be at least 18 years old.

Who cannot join the trial?

4 criteria

  • Patients who do not have a type of cancer called solid tumors with specific gene changes (NTRK1/2/3, ROS1, or ALK) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial groups cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

Entrectinib is a medication being studied for its effectiveness in treating patients with certain types of advanced or metastatic solid tumors. These tumors have specific genetic changes known as NTRK1/2/3, ROS1, or ALK gene rearrangements. The goal of using Entrectinib in this trial is to see how well it can reduce the size of these tumors or stop them from growing.

What is already known about the treatment

Entrectinib – Entrectinib is administered orally and is currently being studied in clinical trials for its effectiveness in treating locally advanced or metastatic solid tumors with specific gene rearrangements, such as NTRK1/2/3, ROS1, or ALK. It is classified as a targeted therapy and works by inhibiting the activity of proteins produced by these gene rearrangements, which are involved in the growth and spread of cancer cells. This medication is part of ongoing research to determine its potential benefits and safety in patients with these genetic profiles.

Investigated diseases

Locally Advanced or Metastatic Solid Tumors with NTRK1/2/3, ROS1, or ALK Gene Rearrangements – These are a group of cancers that have spread beyond their original site and are characterized by specific genetic changes involving the NTRK1, NTRK2, NTRK3, ROS1, or ALK genes. These gene rearrangements can lead to uncontrolled cell growth and tumor development. The progression of these tumors can vary depending on the type of solid tumor and the specific gene rearrangement involved. They may affect various organs and tissues, leading to diverse symptoms based on the tumor's location and size. The presence of these genetic alterations can influence the behavior of the cancer and its response to certain treatments. Understanding these genetic changes is crucial for developing targeted therapies.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505034-10-00Protocol codeGO40782Estimated enrolment586 patientsSponsorF. Hoffmann-La Roche AG

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