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Study on the Effects of Selpercatinib in Patients Aged 12 and Older with Advanced Solid Tumors with RET Gene Alteration

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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 selpercatinib, also known by its code name LOXO-292. The study is aimed at patients with advanced solid tumors, which are a type of cancer that forms in the tissues of the body. Specifically, the trial includes patients with tumors that have a change in a gene called RET. This includes certain types of thyroid cancer, such as medullary thyroid cancer, and other tumors where the RET gene is active.

The purpose of the study is to explore how well selpercatinib works in treating these cancers. The study is divided into two phases. In the first phase, the goal is to find the best dose of the medication that can be used safely. In the second phase, the study will look at how effective the medication is in shrinking the tumors. Patients will take the medication in the form of a capsule that is swallowed. Some patients in the study may receive a placebo, which is a substance with no active medication, to compare the effects.

Throughout the study, patients will have regular check-ups to monitor their health and the effects of the treatment. The study will continue until 2028, allowing researchers to gather enough information to understand the potential benefits and risks of using selpercatinib for treating these types of cancer. This research is important for developing new treatments for patients with advanced solid tumors that have limited options.

The research process

The trial runs in 6 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 assessed to ensure they meet the eligibility criteria. This includes having a locally advanced or metastatic solid tumor with a RET gene alteration.

    The patient must be at least 12 years old and have a life expectancy of at least 3 months.

  2. Step 2

    Initial assessment

    The patient will undergo a series of tests to confirm their health status. This includes checking blood counts, liver and kidney function, and ensuring they can swallow capsules.

    An archived tumor tissue sample may be required for further analysis.

  3. Step 3

    Phase 1 treatment

    The patient will begin taking selpercatinib orally. The dosage will be determined based on the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D).

    The primary goal is to determine the appropriate dosage for further study.

  4. Step 4

    Phase 2 treatment

    In Phase 2, the patient will continue taking selpercatinib at the established dose. The focus will be on assessing the drug's effectiveness in reducing tumor size.

    The patient's response will be evaluated using specific criteria for measuring tumor response.

  5. Step 5

    Regular monitoring

    Throughout the study, the patient will have regular clinic visits for monitoring. This includes laboratory tests and assessments to track the treatment's effects and any side effects.

    The patient must comply with all scheduled visits and tests.

  6. Step 6

    End of study participation

    The study is expected to conclude by May 31, 2028. The patient will continue treatment until the study ends or until they no longer benefit from the treatment.

    After the last dose, the patient will be monitored for at least one month to observe any lasting effects.

Who can join the trial?

14 criteria

  • Patients must be **12 years or older**.
  • Both **male and female** patients can participate.
  • Patients should have a **locally advanced or metastatic solid tumor**. This means the cancer has spread from where it started to nearby areas or other parts of the body.
  • There must be evidence of a **RET gene alteration** in the tumor or blood. A gene alteration is a change in the DNA that can affect how cells grow.
  • For Phase 1, patients must have tried standard treatments and either not responded, cannot tolerate them, or have no standard treatment options available.
  • For Phase 1, patients need a **performance status score** of 0, 1, or 2 if they are 16 years or older, or a Lansky Performance Score of at least 40% if they are younger than 16. This score measures how well patients can perform daily activities.
  • For Phase 1, patients should have a **life expectancy of at least 3 months**.
  • For Phase 1, an **archived tumor tissue sample** must be available. This is a sample of the tumor that was previously collected and stored.
  • For Phase 1, patients need **adequate blood health**, meaning certain blood cell counts must be at a safe level without recent medical support.
  • For Phase 2, patients must have a **measurable lesion**. This is a tumor that can be measured to see if it changes in size during the study.
  • For Phase 1, patients need **adequate liver function**, meaning liver enzymes and bilirubin levels must be within a safe range.
  • For Phase 1, patients need **adequate kidney function**, meaning the kidneys must be able to filter blood at a certain rate.
  • For Phase 1, patients must be able to **swallow capsules** and attend clinic visits.
  • For Phase 1, patients of reproductive potential must agree to use **effective birth control** during the study and for 1 month after the last dose.

Who cannot join the trial?

3 criteria

  • Patients who are younger than 12 years old.
  • Patients who do not have a locally advanced or metastatic solid tumor. This means the cancer has not spread to nearby tissues or other parts of the body.
  • Patients without evidence of a RET gene alteration in their tumor or blood. A RET gene alteration is a change in a specific gene that can affect cancer growth.
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Investigated drugs

Selpercatinib (LOXO-292) is an oral medication being studied for its effects on advanced solid tumors. It is particularly focused on tumors that have a specific genetic change known as RET fusion, as well as medullary thyroid cancer and other tumors with RET activation. The study aims to find the best dose of this medication and to see how well it works in shrinking tumors.

What is already known about the treatment

Selpercatinib – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating advanced solid tumors, particularly those with RET gene alterations. It is in the investigational stage, with ongoing research to determine its optimal dosage and therapeutic potential. Selpercatinib is primarily indicated for patients with locally advanced or metastatic solid tumors, including medullary thyroid cancer and other tumors with RET activation. At the molecular level, it works by selectively inhibiting the RET kinase, which is involved in the growth and spread of cancer cells. It is classified as a targeted cancer therapy, focusing on specific genetic changes in tumors.

Investigated diseases

Solid Tumor with RET Gene Alteration – This condition involves the presence of a solid tumor that has a specific genetic change known as a RET gene alteration. These tumors can occur in various parts of the body and may be locally advanced or have spread to other areas, known as metastatic. The RET gene alteration can affect how the tumor grows and behaves. This type of tumor can be found in both male and female patients who are 12 years or older. The progression of the disease can vary depending on the location and extent of the tumor. Understanding the genetic alteration helps in studying the tumor's characteristics and potential responses to treatments.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-507702-13-00Protocol codeLOXO-RET-17001Estimated enrolment857 patientsSponsorLoxo Oncology Inc.

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