Gastrointestinal Stromal Tumor (GIST)Phase 1NCT03594422
A Study of HQP1351 in Patients With GIST or Other Solid Tumors
A Phase 1 study testing HQP1351 in people with Gastrointestinal Stromal Tumor (GIST) and Solid Tumor, Adult, run by Ascentage Pharma Group Inc. at 6 sites in China.
Trial summary
This study is a Multi-center, Open-label Phase 1 Study to Determine the Recommend Phase 2 Dose (RP2D) and Evaluate PK/PD and preliminary Efficacy of HQP1351 in Patients With GIST or Other Solid Tumors. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumor (GIST), Solid Tumor, Adult
- What is being tested?
- HQP1351
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesChina
- Study dates
- 11 Jul 2018to Dec 2028
- Phase
- Phase 1
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
- Male or not pregnant or lactating women, age≥12years.
- Advanced and/or metastatic GIST or other solid tumors, confirmed by histology and/or cytology. GIST patients must be primary resistant to imatinib (tumor progresses within 6 months first-line imatinib treatment, or succinate dehydrogenase B (SDHB) deficient confirmed by immunohistochemistry, or NF1 mutation), OR imatinib or imatinib and at least one other TKI treatment failure (after imatinib or other TKI treatment for more than 6 months, tumor progress again after achieving tumor remission or stability).
- ECOG≤ 2.
- Estimated survival at least 3 months.
- Adequate hematologic and bone marrow functions.
- Adequate renal and liver function.
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- Heart function index:
- Troponin(I/T) ≤ Upper Limit of Normal;
- Ejection fraction >40%;
- QTc interval ≤ 450 ms in male or ≤ 470 ms in female.
- Negative serum pregnancy test (for women of childbearing potential) documented within the 24-hour prior to the first dose of investigational product.
- Willing to use contraception by a method that is deemed effective by the investigator by Subject and their partners throughout the treatment period and for at least 30 days following the last dose of study drug.
- Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the subject prior to any study-specific procedures).
- Willing and ability to comply with study procedures and follow-up examination.
Who cannot join
- Received any anti-cancer chemotherapy, biological agent treatment (e.g. Monoclonal antibody), immunotherapy (e.g. IFN) or radiotherapy with 28 days or 5 times half- time before first dose of HQP1351.
- Received any TKIs within 14 days before first dose of HQP1351.
- Attended any clinical trials on other drugs within 14 days before first dose of HQP1351.
- Have not recovered (> Grade 1 by CTCAE, v. 4.0) from AEs (except alopecia) due to agents previously administered.
- Malabsorption syndrome or other diseases that affect the absorption of oral drugs.
- Cardiovascular diseases of clinical significance, uncontrollable or active, including but not limited to: history of myocardial infarction; unstable history of angina pectoris; a history of congestive heart failure or lower left ventricular ejection fraction (LVEF) than normal limit within 6 months; the history of atrial arrhythmias was judged by the researchers to have important clinical significance; history of ventricular arrhythmias, etc.
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- Hypertension was still poorly controlled after medication treatment (SBP > 140 mmHg and/or DBP > 90 mmHg).
- Concurrent use any medication led to prolong QT interval.
- Pulmonary mean arterial pressure>35 mmHg by ECHO.
- Significant severe cardiovascular conditions during previous TKI treatment.
- Uncontrollable hypertriglyceridemia.
- Performed major surgery (except for intravenous catheterization or bone marrow biopsy) within 14 days of first dose of HQP1351.
- Arterial thrombosis or embolism events such as cerebrovascular accident (including transient ischemic attack, TIA), or venous thrombosis events or pulmonary embolism within 6 months before the first dose of HQP1351 or deep vein thrombosis within 3 months before the first dose of HQP1351.
- Brain metastasis.
- Had other primary malignant tumors in the last three years (exception of the tumors being cured for 5 years or more, or complete removal of non-melanoma skin cancer or successful treatment of carcinoma in situ, or the controlled prostate cancer).
- Had active, symptomatic infections (including known infections of HIV, viral hepatitis (A, B, or C)). If there is no history of infection, screening is not required.
- Subjects who are known to be allergic to pharmaceutical ingredients or their analogs.
- Pregnancy or lactation, or expect to be pregnant during the study period.
- According to the judgment of the investigator or sponsor, any symptoms or disease of the subject may jeopardize the safety or safety assessment of the subject.
- Any other condition or circumstance of that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Chinese PLA general hospital, Beijing, China
Beijing
Xin Wu, Professor
Xin Wu, Professor
- Recruiting
Sun-Yat Sen University Cancer Center
Guangzhou, Guangdong, 510060
Ruihua Xu, Professor, +86-20-87343468, ruihxu@163.com
Zhiwei Zhou, Professor
- Recruiting
Guangdong general hospital
Guangzhou, Guangdong
Yong Li, Professor
Yong Li, Professor
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Ye Zhou, Professor
Ye Zhou, Professor
- Recruiting
Union Hospital Tongji Medical College of Huazhong University of Science ang Technology
Wuhan, Hubei, 215316
Kaixiong Tao, Ph.D
Kaixiong Tao, Ph.D
- Recruiting
Henan cancer hospital
Zhengzhou, Henan
Xiangbin Wan, Professor
Xiangbin Wan, Professor
About this study
Official title: A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Oral HQP1351 in Patients With GIST or Other Solid Tumors.
This study is a Multi-center, Open-label Phase 1 Study to Determine the Recommend Phase 2 Dose (RP2D) and Evaluate PK/PD and preliminary Efficacy of HQP1351 in Patients With GIST or Other Solid Tumors.
Read the detailed description
The primary objective of this phase 1 study is to determine the RP2D of HQP1351 in patients with GIST or other solid tumors. The secondary objective is to assess the safety, tolerability, PK and preliminary anti-tumor activities of HQP1351 in Patients With GIST or Other Solid Tumors.
- Being tested
- HQP1351
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HQP1351Drug
HQP1351 Orally, once every other day (QOD) for consecutive 4 weeks each cycle.
| Study group | Role | What they receive |
|---|---|---|
| HQP1351 30mg | Experimental | 30 mg QOD(Minor subjects will be enrolled based on weight) Receives: Drug: HQP1351 |
| HQP1351 40mg | Experimental | 40 mg QOD(Minor subjects will be enrolled based on weight) Receives: Drug: HQP1351 |
| HQP1351 50mg | Experimental | 50 mg QOD Receives: Drug: HQP1351 |
| HQP1351 20mg | Experimental | 20 mg QOD (Minor subjects will be enrolled based on weight) Receives: Drug: HQP1351 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerance
Patients with HQP1351 treatment related adverse events (AE), serious adverse events (SAE) will be assessed according NCI CTCAE Version 4.03.
Measured: 30 days after the last dose of HQP1351
Secondary outcomes (3)
Maximum plasma concentration (Cmax) of HQP1351 on Day 1 and Day 27 post HQP1351 treatment on cycle 1.
Pharmacokinetic evaluation
Measured: 28 days
Area under the plasma concentration versus time curve (AUC) of HQP1351 on Day 1 and Day 27 post HQP1351 treatment on cycle 1.
Pharmacokinetic evaluation
Measured: 28 days
Anti-tumor activities of HQP1351
Response will be evaluated every 2 cycles (8 weeks), according to the revised RECIST Guideline, Version 1.1
Measured: 3-60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start11 Jul 2018
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal Stromal Tumor (GIST)Studies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized at 1:1:1 ratio into the three dose cohorts: 30 mg QOD, 40 mg QOD and 50 mg QOD.Non-randomized selected adult subjects will receive a 40 mg QOD dosing regimen. And the minor will be enrolled to the three dose cohorts: 20mg QOD, 30 mg QOD, 40 mg QOD according to the weight.
- Masking
- None (open label)
- Enrolment
- 100 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, Professor, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594422
- Sponsor's protocol ID
- SJ-0003
- Status last verified
- Apr 2026
- First submitted
- 1 Jul 2018
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Qiu HB, Liang Z, Yang J, Zhou Y, Zhou ZW, Wan XB, Li N, Tao KX, Li Y, Wu X, Yang C, Chen Z, Wang H, Men L, Xiong Y, Liu L, Yang D, Zhai Y, Xu RH. Olverembatinib, a multikinase inhibitor that modulates lipid metabolism, in advanced succinate dehydrogenase-deficient gastrointestinal stromal tumors: a phase 1b study and translational research. Signal Transduct Target Ther. 2025 Nov 4;10(1):361. doi: 10.1038/s41392-025-02456-9.
PubMed 41184234