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The-630

A new clinical trial is underway to assess the effectiveness and safety of THE-630, an oral medication designed to treat advanced gastrointestinal stromal tumors (GIST). This study aims to determine the optimal dosage and evaluate the drug’s ability to combat GIST in patients who have not responded well to previous treatments. The trial consists of two phases: a dose escalation phase to establish safety and appropriate dosing, followed by an expansion phase to further examine the drug’s effectiveness in different patient groups.

Table of Contents

What is THE-630?

THE-630 is a new drug being tested for the treatment of gastrointestinal stromal tumors (GIST). It is an oral medication, which means it can be taken by mouth, typically once daily[1]. THE-630 belongs to a class of drugs called KIT tyrosine kinase inhibitors. These drugs work by blocking specific proteins that are involved in the growth and spread of cancer cells[1].

Target Conditions

THE-630 is primarily being studied for the treatment of:

  • Gastrointestinal Stromal Tumors (GIST): These are rare tumors that occur in the digestive tract, most commonly in the stomach or small intestine.
  • Advanced or metastatic GIST: This refers to GIST that has spread to other parts of the body or cannot be surgically removed.
Additionally, the study includes patients with other related conditions such as:
  • Connective tissue neoplasms
  • Soft tissue neoplasms
  • Gastrointestinal neoplasms
  • Digestive system neoplasms
These terms all refer to various types of tumors or cancerous growths in the digestive system or surrounding tissues[1].

How THE-630 Works

THE-630 is a KIT tyrosine kinase inhibitor. To understand how it works:

  • KIT is a protein found on the surface of certain cells, including some cancer cells.
  • In many cases of GIST, the KIT protein is abnormally active, causing uncontrolled cell growth.
  • THE-630 works by blocking (or inhibiting) the activity of the KIT protein.
  • By doing this, it aims to slow down or stop the growth of cancer cells.
This targeted approach is designed to attack cancer cells while potentially causing less harm to normal cells compared to traditional chemotherapy[1].

Clinical Trial Design

The clinical trial for THE-630 is designed in two phases:

  1. Phase 1 (Dose Escalation): This phase aims to:
    • Determine the safety profile of THE-630
    • Identify any dose-limiting toxicities (side effects that prevent increasing the dose)
    • Establish the maximum tolerated dose (MTD)
    • Determine the recommended Phase 2 dose (RP2D)
  2. Phase 2 (Expansion): This phase will:
    • Further assess safety and tolerability
    • Evaluate the anti-tumor activity of THE-630 in different GIST patient populations
The trial includes patients who have already tried other treatments for GIST and either didn’t respond well or couldn’t tolerate them[1].

Safety and Efficacy Assessment

The trial will assess THE-630’s safety and effectiveness through various measures:

  • Safety: Monitoring for adverse events (side effects) using standardized criteria
  • Efficacy: Measuring how well the drug works against the tumor, including:
    • Objective Response Rate (ORR): The proportion of patients whose tumors shrink or disappear
    • Duration of Response (DOR): How long the tumor response lasts
    • Progression-Free Survival (PFS): How long patients live without their cancer getting worse
    • Overall Survival (OS): How long patients live overall
These assessments will help determine if THE-630 is safe and effective for treating GIST[1].

Pharmacokinetics

The trial will also study how THE-630 behaves in the body, known as pharmacokinetics. This includes measuring:

  • Cmax: The maximum concentration of the drug in the blood
  • Tmax: The time it takes to reach the maximum concentration
  • AUC: The total exposure to the drug over time
These measurements will be taken for both THE-630 and its active metabolite (a substance produced when the body processes the drug). Understanding these factors helps determine the optimal dosing schedule for the medication[1].

Patient Groups

The trial includes different groups of GIST patients based on their previous treatments:

  1. 5th Line or Later: Patients who have tried at least four other treatments, including imatinib, sunitinib, regorafenib, and ripretinib.
  2. 3rd-4th Line: Patients who have tried imatinib, sunitinib, and up to one additional therapy.
  3. 2nd Line: Patients who have only tried imatinib and haven’t received any other systemic therapy for advanced GIST.
This approach allows researchers to evaluate how effective THE-630 is for patients at different stages of treatment[1].

Aspect Details
Drug Name THE-630
Drug Type Oral KIT tyrosine kinase inhibitor
Target Condition Advanced Gastrointestinal Stromal Tumors (GIST)
Study Design Phase 1/2 clinical trial
Study Phases Dose escalation (Phase 1) and Expansion (Phase 2)
Primary Objectives Determine safety profile, optimal dosage, and efficacy
Key Measurements Adverse events, dose-limiting toxicities, objective response rate
Patient Population GIST patients with disease progression or intolerance to previous treatments
Treatment Duration Up to 24 months
Administration Once daily, continuous oral regimen

FAQ

  • What is THE-630? THE-630 is an oral medication classified as a KIT tyrosine kinase inhibitor. It is being studied as a potential treatment for advanced gastrointestinal stromal tumors (GIST) in patients who have not responded well to other therapies.
  • Who is eligible to participate in this clinical trial? The trial includes patients with unresectable or metastatic GIST who have experienced disease progression or intolerance to previous treatments such as imatinib, sunitinib, regorafenib, ripretinib, or avapritinib. Different cohorts in the expansion phase target patients at various stages of treatment history.
  • How is the drug administered? THE-630 is taken orally (by mouth) once daily in a continuous regimen. The exact dosage will be determined during the dose escalation phase of the trial.
  • What are the main goals of this clinical trial? The primary objectives are to determine the safety profile of THE-630, including its side effects and optimal dosage, and to evaluate its effectiveness in treating GIST. The trial will measure factors such as tumor response rate, duration of response, and overall survival.
  • How long will participants be monitored during the trial? Participants will be monitored for up to 24 months after receiving their first dose of THE-630. During this time, researchers will assess various outcomes related to the drug's safety and effectiveness.

Ongoing Clinical Trials on The-630

  • Study on the Safety and Effectiveness of THE-630 for Patients with Advanced Gastrointestinal Stromal Tumors (GIST)

    Not recruiting

    2 1 1
    Investigated drugs:
    France Spain

Glossary

  • Gastrointestinal Stromal Tumors (GIST): A type of cancer that occurs in the digestive system, typically in the stomach or small intestine. GISTs are rare tumors that develop from special cells in the wall of the digestive tract.
  • Unresectable: A term used to describe a tumor that cannot be completely removed through surgery, often due to its size, location, or spread to other parts of the body.
  • Metastatic: Refers to cancer that has spread from its original site to other parts of the body.
  • KIT tyrosine kinase inhibitor: A type of drug that blocks the action of a specific enzyme called KIT tyrosine kinase, which is often overactive in GIST cells. By inhibiting this enzyme, the drug aims to slow down or stop tumor growth.
  • Dose-limiting toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dosage or require a reduction in dosage.
  • Maximum tolerated dose (MTD): The highest dose of a drug that can be given without causing unacceptable side effects.
  • Pharmacokinetics: The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and eliminated.
  • Objective response rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a set of rules used to measure how well a cancer patient responds to treatment.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with cancer without it getting worse.
  • Overall survival (OS): The length of time from the start of treatment that patients are still alive.

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