Can a targeted pill shrink a rare, Treatment-Resistant stomach cancer?

NCT ID NCT06640361

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether the experimental drug olverembatinib can slow or stop tumor growth in people with a rare form of gastrointestinal stromal tumor (GIST) that lacks a key enzyme called SDH. The study enrolls adults whose cancer has progressed after at least one prior treatment. Participants take olverembatinib by mouth every other day, and researchers will track how long the cancer stays under control and what side effects occur.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a drug called olverembatinib, taken by mouth every other day
What this could lead to
If successful, this could provide a new treatment option for people with a rare, hard-to-treat form of stomach cancer that has stopped responding to other therapies.
What could go wrong
This is a small, single-arm trial with no comparison group, so results may be less definitive. Side effects are possible, and the drug may not work for everyone.
Why investors are watching

Ascentage Pharma is running a phase 3 trial of its drug olverembatinib in patients with a rare type of gastrointestinal stromal tumor (GIST) that lacks a specific enzyme called SDH. The trial enrolls only 40 patients who have already tried one prior therapy, and a positive result could serve as the basis for regulatory approval. For a small company, this single registrational study carries outsized weight because its outcome directly affects the value of the drug and the company's future.

If it works: If the trial shows that olverembatinib controls the disease and delays progression, Ascentage could gain approval for a niche but defined patient group. That approval would give the company a new marketed product and a clearer path to revenue.

If it fails: The trial could fail to show enough benefit, or the small patient pool could make results hard to interpret. Trials in cancer often fail, and a negative or delayed readout would likely hurt the company's prospects and its stock.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically and/or cytologically confirmed GIST, immunohistochemistry with loss of SDHB expression, and failure of at least one prior systemic therapy. Defined as disease progression or intolerable as judged by the investigator. 2. Must have at least one measurable target lesion. 3. ECOG≤ 2. 4. Expected survival of at least 3 months. 5. Adequate organ function. 6. Negative serum pregnancy test result for women of childbearing potential within 7 days prior to taking the first dose of study drug. 7. Males, women of childbearing potential, as well as their partners, voluntarily take effective contraceptive measures as specified in the protocol from the time of signing the informed consent form until at least 30 days after the last dose of study drug. 8. Prior to initiation of any screening or study-specific procedures, the patient or his/her guardian is able to understand and voluntarily sign an informed consent form approved by the Ethics Committee in writing, voluntarily and able to complete the study procedures and follow-up examinations. Exclusion Criteria: 1. Received antitumor cytotoxic chemotherapy, radiotherapy, biologic drug therapy, immunotherapy, or other investigational agents within 14 days or less than 5 times the half-life prior to the first dose. 2. Tyrosine kinase inhibitor (TKI) therapy within 7 days prior to the first dose. 3. Use of drugs that have drug interactions with the study drug within 7 days prior to the first dose. 4. Adverse events due to prior treatment have not recovered (\> NCI CTCAE v5.0 Grade 1). 5. Absorption disorder syndrome or other conditions that affect the absorption of oral medications. 6. With clinically significant, uncontrolled or active cardiovascular disease or thrombotic disease. 7. Poorly controlled hypertension after hypertension medication. 8. Severe cardiovascular and cerebrovascular diseases during previous use of TKIs. 9. Uncontrolled Hyperlipidemia. 10. Major surgery, open biopsy, or major traumatic injury within 14 days prior to initiation of study drug. 11. With brain metastases. 12. Other malignancies within 2 years. 13. Uncontrolled systemic active fungal, bacterial, and/or viral infections. 14. Female patients who are pregnant or lactating, or female patients who are expecting to become pregnant within the period of this study. 15. Any symptoms or disease of the patient, in the judgment of the investigator or sponsor, that may jeopardize their safety or interfere with the safety evaluation of the investigational drug.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510000, China

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