Actively Recruiting
An Open Label, Multicenter Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-8364 in the Treatment of Advanced Solid Tumor Subjects
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2026-04-03
282
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an open, multicenter Phase I/II clinical trial to study HRS-8364 in adults with advanced solid tumors. The study aims to evaluate the safety, tolerability, pharmacokinetics, and effectiveness of HRS-8364 in patients whose cancer has progressed despite standard treatments or who have no standard treatment options. This trial is sponsored by Jiangsu HengRui Medicine Co., Ltd. Participants will receive HRS-8364 tablets at various doses through different stages of the study: dose escalation, dose expansion, and efficacy expansion. The trial will assess the best dose for further study, monitor side effects, and evaluate the drug's impact on tumor response. Treatment and follow-up will last about one year, with close monitoring of drug levels and patient health. During the trial, participants will undergo regular assessments including evaluations of tumor size based on RECIST criteria, safety checks, and blood tests to monitor drug concentration and effects. Researchers will track outcomes like dose-limiting toxicity, response rates, disease control, and progression-free survival. The study includes safety follow-up and requires participants to comply with contraception guidelines if applicable, lasting from enrollment through about one year of treatment and follow-up.
CONDITIONS
Brief Title
A Clinical Study of HRS-8364 in the Treatment of Advanced Solid Tumor Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to join the study and sign informed consent
- Age between 18 and 75 years old, any gender
- Diagnosed with advanced solid tumors by cytology or histology
- For dose escalation: tumors failed or are intolerant to standard treatment or have no standard treatment
- For dose expansion: tumors with progression during or after other systemic treatments
- For efficacy expansion: tumors with progression during or after other systemic treatments
- Have at least one measurable tumor lesion according to RECIST v1.1
- ECOG performance status score of 0 to 1
- Expected survival of at least 12 weeks
- Agree to use effective contraception if of reproductive potential and avoid donating eggs or sperm during and 30 days after treatment
- Female participants must have a negative pregnancy test before starting treatment and must not be breastfeeding
You will not qualify if you...
- Untreated brain metastases or meningeal metastasis or spinal cord compression
- Tumor invading large blood vessels with high risk of fatal bleeding
- Uncontrolled pleural, pericardial, or peritoneal effusion with symptoms
- Severe bone damage from bone metastasis including uncontrolled pain, recent or expected pathological fractures, or spinal cord compression
- Other malignant tumors within past 5 years or concurrent
- Major arterial or venous blood clots within 6 months before treatment
- Active or past interstitial lung disease needing treatment or severe lung dysfunction
- Active pulmonary tuberculosis unless treated and treatment stopped for at least 3 months
- Known HIV infection or active viral hepatitis
- Unable to swallow pills normally or with gastrointestinal dysfunction affecting absorption
- History of intestinal obstruction or gastrointestinal perforation within 3 months before treatment
- Other serious illnesses, mental conditions, substance abuse, or social factors affecting safety or study compliance as judged by researchers
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 - Up to about 1 year
Participants receive HRS-8364 tablets in different doses to treat advanced solid tumors.
Regular visits during treatment period
Duration - Up to about 1 year after treatment
Participants are monitored for safety and treatment outcomes after completing treatment.
Visits as needed for safety follow-up
Trial Site Locations
Total: 2 locations
1
The Sixth Affiliated Hospital, Sun-Yat-Sen University
Guangzhou, Guangdong, China, 510655
Actively Recruiting
2
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China, 110042
Actively Recruiting
Research Team
C
Cong Wen
W
Weixia Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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