Can a targeted pill shrink a rare, Treatment-Resistant stomach cancer?
NCT ID NCT06640361
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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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
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510000, China
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Other studies related to the condition(s) this trial covers.
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- Massive GIST registry aims to unlock secrets of rare cancer
- New hope for stomach cancer patients Who've tried everything?
- New hope for GIST: experimental combo targets hard-to-treat tumors