GISTPhase 3NCT06640361
A Study of Olverembatinib in SDH-deficient GIST.
A Phase 3 study testing Olverembatinib in people with GIST, run by Ascentage Pharma Group Inc. at 1 site in China.
Trial summary
An international multicenter, open, single-arm pivotal registration phase III study to determine the efficacy and safety of olverembatinib in patients with SDH-deficient gastrointestinal stromal tumor (GIST) who have previously been treated with one-line therapy, and to evaluate the progression-free survival and… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- GIST
- What is being tested?
- Olverembatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2024to 30 Jun 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- Must have at least one measurable target lesion.
- ECOG≤ 2.
- Expected survival of at least 3 months.
- Adequate organ function.
- Negative serum pregnancy test result for women of childbearing potential within 7 days prior to taking the first dose of study drug.
- 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.
- 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.
Who cannot join
- 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.
- Tyrosine kinase inhibitor (TKI) therapy within 7 days prior to the first dose.
- Use of drugs that have drug interactions with the study drug within 7 days prior to the first dose.
- Adverse events due to prior treatment have not recovered (> NCI CTCAE v5.0 Grade 1).
- Absorption disorder syndrome or other conditions that affect the absorption of oral medications.
- With clinically significant, uncontrolled or active cardiovascular disease or thrombotic disease.
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- Poorly controlled hypertension after hypertension medication.
- Severe cardiovascular and cerebrovascular diseases during previous use of TKIs.
- Uncontrolled Hyperlipidemia.
- Major surgery, open biopsy, or major traumatic injury within 14 days prior to initiation of study drug.
- With brain metastases.
- Other malignancies within 2 years.
- Uncontrolled systemic active fungal, bacterial, and/or viral infections.
- Female patients who are pregnant or lactating, or female patients who are expecting to become pregnant within the period of this study.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chen Yang, M.D. contact
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Ruihua Xu, M.D.,Ph.D., 020-87343468, xurh@sysucc.org.cn
Ruihua Xu, M.D.,Ph.D.
About this study
Official title: A Single-Arm Registrational Phase III Study of Olverembatinib in the Treatment of Patients With SDH-Deficient Gastrointestinal Stromal Tumor (POLARIS-3)
An international multicenter, open, single-arm pivotal registration phase III study to determine the efficacy and safety of olverembatinib in patients with SDH-deficient gastrointestinal stromal tumor (GIST) who have previously been treated with one-line therapy, and to evaluate the progression-free survival and clinical benefit rate of olverembatinib in patients with SDH-deficient GIST.
Read the detailed description
This study intends to enroll patients with SDH-deficient GIST who have failed at least one systemic therapy to receive olverembatinib tablets 40mg orally administered with meals once every other day and every 28 days for a dosing cycle.
- Conditions
- GIST
- Being tested
- Olverembatinib
- Keywords
- Olverembatinib, GIST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlverembatinibDrug
Oral administration with meal, QOD, every 28 days for a cycle.
| Study group | Role | What they receive |
|---|---|---|
| Olverembatinib | Experimental | Not described Receives: Drug: Olverembatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival(PFS) rate
Proportion of subjects who do not experience disease progression or death after the first dose of treatment as assessed by Independent Review Committee.
Measured: 36 months
Secondary outcomes (2)
Plasma concentrations of olverembatinib
Blood samples will be collected to measure the plasma concentration of olverembatinib.
Measured: Cycle 2 to Cycle 3 (each cycle is 28 days)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
According to CTCAE v5.0, the number and frequency of adverse events of test drug were assessed.
Measured: Through study completion,an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start11 Nov 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GISTStudies of the same condition, open and under way.
- More trials run by Ascentage Pharma Group Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascentage Pharma Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- HealthQuest Pharma Inc.
- Responsible party
- Sponsor
- Investigators
- Ruihua Xu, M.D., Ph.D., Study chair, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640361
- Sponsor's protocol ID
- HQP1351GG301
- Status last verified
- Jul 2026
- First submitted
- 11 Oct 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Registrational Phase III Study of Olverembatinib in the Treatment of Patients With SDH-Deficient Gastrointestinal Stromal Tumor (POLARIS-3)
- ClinicalTrials.gov ID
- NCT06640361
- Acronym / sponsor ID
- HQP1351GG301
- Conditions
- GIST
- Keywords
- Olverembatinib, GIST
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ascentage Pharma Group Inc.Industry (pharma, biotech, devices)
- Collaborators
- HealthQuest Pharma Inc.
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An international multicenter, open, single-arm pivotal registration phase III study to determine the efficacy and safety of olverembatinib in patients with SDH-deficient gastrointestinal stromal tumor (GIST) who have previously been treated with one-line therapy, and to evaluate the progression-free survival and clinical benefit rate of olverembatinib in patients with SDH-deficient GIST.
Detailed description
This study intends to enroll patients with SDH-deficient GIST who have failed at least one systemic therapy to receive olverembatinib tablets 40mg orally administered with meals once every other day and every 28 days for a dosing cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Olverembatinib | Experimental | Drug: Olverembatinib |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Must have at least one measurable target lesion.
- ECOG≤ 2.
- Expected survival of at least 3 months.
- Adequate organ function.
Key exclusion criteria (15 listed)
- 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.
- Tyrosine kinase inhibitor (TKI) therapy within 7 days prior to the first dose.
- Use of drugs that have drug interactions with the study drug within 7 days prior to the first dose.
- Adverse events due to prior treatment have not recovered (> NCI CTCAE v5.0 Grade 1).
- Absorption disorder syndrome or other conditions that affect the absorption of oral medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlverembatinibOral administration with meal, QOD, every 28 days for a cycle. | Drug | Olverembatinib |
Primary outcome
Progression-free survival(PFS) rate
Time frame: 36 months
Proportion of subjects who do not experience disease progression or death after the first dose of treatment as assessed by Independent Review Committee.
2 secondary outcomes
Plasma concentrations of olverembatinib
Time frame: Cycle 2 to Cycle 3 (each cycle is 28 days)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time frame: Through study completion,an average of 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chen Yang, M.D. contact
Ruihua Xu, M.D., Ph.D. study chair
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olverembatinib in people with GIST, run by Ascentage Pharma Group Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yifan Zhai, M.D., Ph.D. (+86-20-28068501, yzhai@ascentage.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival(PFS) rate (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.