Actively Recruiting
A Study of HQP1351 in Patients With GIST or Other Solid Tumors
Led by Ascentage Pharma Group Inc. · Updated on 2026-04-09
100
Participants Needed
6
Research Sites
542 weeks
Total Duration
On this page
Sponsors
A
Ascentage Pharma Group Inc.
Lead Sponsor
H
HealthQuest Pharma Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of HQP1351 in Patients With GIST or Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or non-pregnant, non-lactating female aged 12 years or older
- Diagnosis of advanced or metastatic GIST or other solid tumors confirmed by histology or cytology
- For GIST: primary resistance to imatinib or failure of imatinib and at least one other TKI treatment
- ECOG performance status of 2 or less
- Estimated survival of at least 3 months
- Adequate blood, bone marrow, kidney, and liver function
- Heart function with troponin I or T within normal limits, ejection fraction above 40%, and QTc interval below 450 ms for males or 470 ms for females
- Negative pregnancy test for women of childbearing potential within 24 hours before first dose
- Willingness to use effective contraception during treatment and for 30 days after last dose
- Ability to understand and sign informed consent
- Willingness and ability to comply with study procedures and follow-up
You will not qualify if you...
- Received chemotherapy, biological agents, immunotherapy, or radiotherapy within 28 days or five half-lives before first dose of HQP1351
- Received tyrosine kinase inhibitors within 14 days before first dose
- Participation in other clinical trials within 14 days before first dose
- Not recovered from previous adverse events above grade 1 (except hair loss)
- Malabsorption syndrome or diseases affecting oral drug absorption
- Significant or uncontrolled cardiovascular diseases including recent myocardial infarction, unstable angina, heart failure, or serious arrhythmias
- Poorly controlled hypertension (systolic >140 mmHg or diastolic >90 mmHg)
- Use of medications that prolong QT interval
- Pulmonary arterial pressure over 35 mmHg
- Severe cardiovascular conditions during previous TKI treatment
- Uncontrolled high triglycerides
- Major surgery within 14 days before first dose (except catheterization or bone marrow biopsy)
- Recent arterial thrombosis, embolism, or deep vein thrombosis within specified timeframes
- Brain metastases
- Other primary cancers within last 3 years (with exceptions for certain cured or treated cancers)
- Active infections including HIV or viral hepatitis
- Known allergy to study drug ingredients
- Pregnancy or lactation
- Any condition deemed unsafe or unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Sun-Yat Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
Guangdong general hospital
Guangzhou, Guangdong, China
Actively Recruiting
3
Henan cancer hospital
Zhengzhou, Henan, China
Actively Recruiting
4
Union Hospital Tongji Medical College of Huazhong University of Science ang Technology
Wuhan, Hubei, China, 215316
Actively Recruiting
5
Chinese PLA general hospital, Beijing, China
Beijing, China
Actively Recruiting
6
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
Y
Yifan Zhai, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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