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Study on the Safety and Effectiveness of THE-630 for Patients with Advanced 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). These tumors occur in the digestive tract and can be challenging to treat, especially in advanced stages. The study is testing a new treatment called THE-630, which is a capsule taken by mouth. This medication is a synthetic small molecule that works as a tyrosine kinase inhibitor, a type of drug that blocks certain proteins that help cancer cells grow.

The purpose of the study is to evaluate the safety and effectiveness of THE-630 in patients with advanced GIST. The study is divided into two phases. In the first phase, the focus is on determining the safety of the drug and finding the right dose. In the second phase, the study will look at how well the drug works in controlling the tumor. Participants will take the medication and attend regular check-ups to monitor their health and the tumor's response to the treatment.

Throughout the study, some participants may receive a placebo, which is a substance with no active medication, to compare the effects of THE-630. The study aims to provide valuable information on the potential benefits and risks of this new treatment for patients with advanced Gastrointestinal Stromal Tumors.

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

    Initial visit

    Upon joining the study, you will attend an initial visit. During this visit, you will undergo a series of assessments to confirm your eligibility for the trial. This includes a review of your medical history, a physical examination, and various laboratory tests.

    You will be asked to provide a tumor biopsy sample if available, which will be used for mutational testing. This sample should ideally be obtained after your most recent prior systemic anticancer therapy.

  2. Step 2

    Consent and agreement

    You will be required to sign an informed consent form. This document confirms that you have been informed about all important aspects of the study and agree to participate.

    If you are a female of childbearing potential, you must agree to use a highly effective form of contraception during the study and for at least 7 months after the end of treatment. Male participants with partners of childbearing potential must agree to use condoms and ensure their partners use effective contraceptive methods during the study and for at least 4 months after the last dose.

  3. Step 3

    Treatment phase 1

    In the first phase of the trial, known as the dose escalation phase, you will receive the study medication, THE-630, in the form of a hard capsule taken orally.

    The purpose of this phase is to determine the safety profile of the medication and identify the appropriate dosage. You will be monitored closely for any side effects or adverse reactions.

  4. Step 4

    Treatment phase 2

    If you continue to the second phase, known as the expansion phase, the focus will be on assessing the anti-tumor activity of THE-630.

    You will continue to take the medication orally, and your response to the treatment will be evaluated through regular assessments, including imaging tests to measure tumor size and progression.

  5. Step 5

    Regular follow-ups

    Throughout the trial, you will have scheduled visits to monitor your health and the effects of the treatment. These visits will include physical exams, blood tests, and other necessary evaluations.

    Your participation will be closely monitored to ensure your safety and to gather data on the effectiveness of the treatment.

  6. Step 6

    End of treatment

    At the end of your treatment period, you will have a final evaluation to assess your overall health and the outcomes of the study.

    You will be advised on any necessary follow-up care and the continuation of any required monitoring post-trial.

Who can join the trial?

13 criteria

  • Must be a male or female who is at least 18 years old.
  • Women who can have children must agree to avoid pregnancy by not having heterosexual intercourse or using a highly effective form of birth control during the study and for at least 7 months after the study ends. Men with partners who can have children must agree to use condoms and ensure their partners use effective birth control during the study and for at least 4 months after the last dose of the study drug.
  • Any side effects from previous treatments must have improved to a mild level or returned to the way they were before treatment when starting the study drug. Some specific side effects like hair loss, nerve damage, or thyroid issues are allowed if they are not expected to improve.
  • Must have signed a consent form, indicating understanding of the study details. If unable to sign due to legal reasons, a legal guardian may sign if allowed by local laws.
  • Must be willing and able to attend scheduled visits and follow study procedures without any medical reasons preventing participation.
  • For the Dose Escalation Phase (Phase 1): Must have a confirmed diagnosis of unresectable (cannot be removed by surgery) or metastatic (spread to other parts of the body) GIST and have not responded to or cannot tolerate certain medications like imatinib and at least one other specified drug.
  • For the Expansion Phase (Phase 2): Must have a confirmed diagnosis of unresectable or metastatic GIST and meet specific criteria based on previous treatments, which vary by cohort.
  • Must have at least one measurable tumor as defined by specific medical guidelines.
  • Must have a tumor sample available for genetic testing, preferably taken after the most recent cancer treatment.
  • Must have a performance status score of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale, which measures daily living abilities.
  • Must have adequate kidney and liver function based on specific medical tests.
  • Must have adequate bone marrow function, which includes having enough white blood cells, platelets, and hemoglobin.
  • For women who can have children, a negative pregnancy test is required within 7 days before starting the study drug. Women who cannot have children due to menopause or surgery do not need this test.

Who cannot join the trial?

4 criteria

  • Patients who have not been diagnosed with Gastrointestinal Stromal Tumors (GIST) 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 group 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

THE-630 is an experimental medication being tested for its ability to treat advanced gastrointestinal stromal tumors, which are a type of cancer that occurs in the digestive tract. This medication is taken by mouth and works by blocking a specific protein called KIT, which is often involved in the growth of these tumors. The study aims to find out how safe THE-630 is for patients, how the body processes it, and how effective it is in reducing or controlling the tumors. The trial is divided into two parts: the first part focuses on determining the safest dose to use, while the second part looks at how well the medication works in treating the cancer.

What is already known about the treatment

THE-630 – THE-630 is an oral medication currently being studied in clinical trials for its potential to treat advanced Gastrointestinal Stromal Tumors (GIST). It is in the early stages of research, specifically Phase 1 and Phase 2 trials, where its safety, how the body processes it, and its ability to fight tumors are being evaluated. The main therapeutic use of THE-630 is to target and inhibit a protein called KIT, which is often involved in the growth of these tumors. By blocking this protein, THE-630 aims to slow down or stop the progression of the cancer. It belongs to a class of drugs known as KIT inhibitors, which are designed to interfere with specific pathways that cancer cells use to grow and survive.

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 vary in size and may grow slowly or more rapidly, depending on their specific characteristics. As they progress, they may cause symptoms such as abdominal pain, bleeding, or a feeling of fullness. The growth of these tumors can lead to complications if they obstruct the digestive tract or spread to other parts of the body. The progression of GISTs is influenced by genetic mutations that affect cell growth and division.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2022-502087-21-00Protocol codeTHE630-21-101Estimated enrolment160 patientsSponsorTheseus Pharmaceuticals Inc.

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