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Study of IDRX-42 for Patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors (GIST)

Verified siteInvestigationalNo 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 a type of cancer known as gastrointestinal stromal tumors (GIST), which can be either metastatic, meaning it has spread to other parts of the body, or unresectable, meaning it cannot be removed with surgery. The treatment being tested in this study is a new medication called IDRX-42, which is a small molecule designed to specifically target and inhibit certain proteins known as tyrosine kinases that are involved in the growth of cancer cells.

The purpose of the study is to determine the best dose and schedule for taking IDRX-42 and to further understand its safety and effectiveness in treating patients with GIST. Participants in the study will receive IDRX-42 in the form of either tablets or capsules, which are taken orally. The study will be conducted in phases, starting with determining the maximum dose that can be tolerated and then moving on to assess the safety and potential benefits of the treatment.

Throughout the study, participants will be monitored for any side effects and the impact of the treatment on their cancer. The study aims to provide valuable information on how IDRX-42 can be used to help patients with GIST, potentially offering a new treatment option for those with this challenging condition. Participants will be required to attend regular visits for assessments and to follow the study's treatment plan. The study is expected to continue until 2026, with the goal of gathering comprehensive data on the use of IDRX-42 in treating GIST.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, medical history, and current health status.

    Eligibility criteria include being 18 years or older, having a confirmed diagnosis of metastatic or unresectable gastrointestinal stromal tumors (GIST), and documented progression on previous treatments.

  2. Step 2

    Treatment phase 1

    The first phase of treatment involves determining the maximum tolerated dose of the medication IDRX-42. This phase focuses on safety and identifying the appropriate dosage.

    Participants receive IDRX_tablets 50mg or IDRX_20mg Capsule or IDRX_100 mg Capsule or tablets 100mg orally. The specific dosage and schedule are adjusted based on individual tolerance and response.

  3. Step 3

    Monitoring and evaluation

    Throughout the trial, regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes tracking any side effects and changes in health status.

    Participants undergo routine laboratory tests and imaging studies to evaluate the response to the treatment.

  4. Step 4

    Treatment phase 1b

    In the second phase, the focus is on further characterizing the safety and efficacy of IDRX-42. This phase aims to evaluate the antitumor activity of the medication.

    Participants continue to receive the medication orally, with adjustments made as necessary based on ongoing assessments.

  5. Step 5

    Completion and follow-up

    Upon completion of the treatment phases, a final evaluation is conducted to assess the overall outcomes and any long-term effects.

    Participants may be asked to attend follow-up visits to monitor their health status and gather additional data for the study.

Who can join the trial?

12 criteria

  • Must be at least 18 years old, unless local rules require a different age for adults.
  • Must have a confirmed diagnosis of **metastatic** (cancer that has spread) and/or **unresectable** (cannot be removed by surgery) **gastrointestinal stromal tumors (GIST)**.
  • Must show that the disease has worsened after taking a medication called **imatinib**.
  • Must have a specific genetic change called a **mutation** in either **KIT** or any **PDGFRA** gene, except for exon 18 mutations, as determined by local testing.
  • Must have at least one tumor that can be measured using a specific method called **mRECIST v1.1**.
  • Must have an **ECOG performance status** of 0 or 1, which means being fully active or having some symptoms but still able to do light work.
  • Any side effects from previous treatments must have improved to a mild level or returned to the state before treatment, except for certain conditions like hair loss, nerve damage, or low thyroid function that are considered permanent.
  • Must be willing and able to follow the study schedule, take the study medication, and undergo tests and procedures required by the study.
  • For specific groups in the study:
    • Group 1: Must have worsened after taking imatinib only and cannot or do not want to try other standard treatments.
    • Group 2: Must have worsened after taking imatinib and another drug called **sunitinib**, or after taking imatinib, sunitinib, and another drug like **regorafenib** or **ripretinib**.
    • Group 3 (only in the US, UK, China, and South Korea): Must not have had any treatment yet and cannot or do not want to try other standard treatments.
    • Group 4: Must meet the same criteria as Group 2 and have also tried other experimental treatments or a combination of drugs like **bezuclastinib** and sunitinib.

Who cannot join the trial?

6 criteria

  • Patients who have other types of cancer that are not **gastrointestinal stromal tumors (GIST)**. GIST is a type of tumor that occurs in the digestive system.
  • Patients who have had surgery to remove their GIST tumors. **Unresectable** means the tumor cannot be removed by surgery.
  • Patients who are not able to tolerate the study medication or have had severe reactions to similar medications in the past.
  • Patients who are pregnant or breastfeeding, as the study medication may affect the baby.
  • Patients who have other serious health conditions that could interfere with the study or make it unsafe for them to participate.
  • Patients who are unable to follow the study procedures or attend the required visits.
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Investigated drugs

IDRX-42 is an investigational medication being studied for its potential use in treating patients with gastrointestinal stromal tumors (GIST) that are either metastatic, meaning they have spread to other parts of the body, or unresectable, meaning they cannot be removed surgically. The study aims to determine the safest and most effective dose of IDRX-42 and to evaluate its safety, tolerability, and ability to reduce tumor size or slow tumor growth in these patients.

What is already known about the treatment

IDRX-42 – IDRX-42 is an investigational medication currently being studied in clinical trials for its potential use in treating metastatic and/or unresectable gastrointestinal stromal tumors (GIST). It is administered orally, allowing for easy application. The medication is in the early stages of clinical research, specifically in a Phase 1 trial, which aims to determine the maximum tolerated dose and assess its safety and efficacy. IDRX-42 is designed to target specific molecular pathways involved in tumor growth, potentially inhibiting the proliferation of cancer cells. It falls under the pharmacological classification of targeted cancer therapies, focusing on specific proteins or genes that contribute to cancer development.

Investigated diseases

Gastrointestinal Stromal Tumors (GIST) – Gastrointestinal stromal tumors are a type of tumor that occurs in the digestive tract, most commonly in the stomach or small intestine. These tumors originate from special cells in the wall of the gastrointestinal tract known as interstitial cells of Cajal. GISTs can be benign or malignant, and their behavior can vary widely. When they become metastatic, they spread to other parts of the body, making them more challenging to treat. Unresectable GISTs are those that cannot be removed surgically due to their location or size. The progression of GISTs can lead to symptoms such as abdominal pain, bleeding, or obstruction, depending on their size and location.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514930-19-00Protocol codeIDRX-42-001 (300382)Estimated enrolment270 patientsSponsorIdrx Inc.

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