Actively Recruiting
A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Oral 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
52 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
Researchers are evaluating HQP1351, an oral drug, in patients aged 12 years and older with gastrointestinal stromal tumors (GIST) or other solid tumors that are advanced or metastatic. This phase 1, multi-center, open-label study aims to find the recommended dose for phase 2 and assess how the drug behaves in the body, its safety, and its preliminary effects on tumors. The trial is sponsored by Ascentage Pharma Group Inc. and uses a randomized design without masking. Participants receive HQP1351 orally once every other day for consecutive 4-week cycles. The study includes several dose groups: 20 mg, 30 mg, 40 mg, and 50 mg every other day, with minor subjects enrolled based on weight. The treatment period continues with dose adjustments to find the optimal dose. The study focuses on safety, tolerability, pharmacokinetics, and pharmacodynamics of HQP1351. During the study, participants are monitored for safety and treatment tolerance up to 30 days after the last dose. Researchers measure the drug's concentration in plasma on specific days of the first cycle and observe anti-tumor activity over months. Participants undergo evaluations of blood counts, organ function, heart function, pregnancy testing for women, and follow study procedures including consent and follow-up visits. The trial is expected to continue until December 2028.
CONDITIONS
Brief 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 female who is not pregnant or lactating, aged 12 years or older
- Diagnosis of advanced and/or metastatic gastrointestinal stromal tumor (GIST) or other solid tumors confirmed by biopsy
- For GIST, must be resistant to imatinib or have failed imatinib and at least one other tyrosine kinase inhibitor treatment
- Performance status (ECOG) of 2 or less
- Expected survival of at least 3 months
- Adequate blood, bone marrow, kidney, and liver function
- Heart function within specified limits including troponin levels, ejection fraction over 40%, and QTc interval within defined limits
- 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 follow study procedures and attend follow-up visits
You will not qualify if you...
- Received any anti-cancer chemotherapy, biological treatment, immunotherapy, or radiotherapy within 28 days before first dose
- Taken any tyrosine kinase inhibitors within 14 days before first dose
- Participation in other drug clinical trials within 14 days before first dose
- Not recovered from side effects of previous treatments except hair loss
- Conditions affecting oral drug absorption
- Significant uncontrolled cardiovascular diseases or conditions
- Poorly controlled high blood pressure despite medication
- Use of medications that prolong QT interval
- Pulmonary arterial pressure above 35 mmHg by echocardiogram
- Severe cardiovascular conditions during previous tyrosine kinase inhibitor treatment
- Uncontrolled high triglyceride levels
- Major surgery within 14 days before first dose
- Recent arterial or venous thrombotic events within specified time frames
- Brain metastases
- Other primary cancers within last three years except certain treated cancers
- Active symptomatic infections including HIV or viral hepatitis
- Allergies to study drug ingredients
- Pregnancy, lactation, or plans to become pregnant during study
- Any condition judged by investigators to affect safety or suitability for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 4-week cycles until disease progression or discontinuation
Participants receive HQP1351 orally once every other day for consecutive 4-week cycles to assess safety, tolerability, and anti-tumor activity.
Visits every other day for dosing and regular safety assessments during each 4-week cycle
Duration - 30 days after last treatment dose
Participants are monitored for safety and tolerance for 30 days after the last dose of HQP1351.
1 to 2 visits for safety follow-up
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.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here