Actively Recruiting
A Clinical Study 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
193 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an open, multicenter, Phase I/II clinical trial, divided into three stages: dose escalation, dose expansion and efficacy expansion.
CONDITIONS
Official 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 joining this study, signing an informed consent form, and able to comply with follow-up
- Age between 18 and 75 years old, males and females eligible
- Advanced solid tumors diagnosed by cytology or histology, with failed or intolerant standard treatment or no standard treatment for dose escalation stage
- Advanced solid tumors with disease progression during or after other systemic treatments for dose expansion and efficacy expansion stages
- Participants in combined dose expansion may not have prior treatment with immuno checkpoint inhibitors
- At least one measurable lesion meeting RECIST v1.1 criteria
- ECOG Performance Status score of 0 or 1
- Expected survival of at least 12 weeks
- Female participants of reproductive potential and male partners must agree to use effective contraception during and 30 days after treatment, with no fertility plans or donation of eggs/sperm
- Female participants with reproductive potential must have a negative pregnancy test within 7 days before first dose and not be breastfeeding
You will not qualify if you...
- Untreated brain metastases, meningeal metastasis, or spinal cord compression
- Large blood vessel invasion by tumor or high risk of fatal bleeding during treatment
- Uncontrolled pleural, pericardial, or peritoneal effusion with symptoms
- Severe bone damage from tumor metastasis, including uncontrolled severe bone pain or recent pathological fractures
- Other malignant tumors within past 5 years or simultaneously
- Major arterial or venous thrombotic events within 6 months before first medication
- Past or current active interstitial lung disease requiring treatment or active pneumonia or severe pulmonary dysfunction
- Active pulmonary tuberculosis unless treated and off therapy for at least 3 months
- Known HIV/AIDS or active viral hepatitis infection
- Unable to swallow pills normally or gastrointestinal dysfunction affecting drug absorption
- Intestinal obstruction or gastrointestinal perforation within 3 months prior to first medication
- Other factors judged by researchers that may affect study results or safety, including alcohol or drug abuse, serious illnesses, mental illness requiring treatment, serious lab abnormalities, or social factors
AI-Screening
AI-Powered Screening
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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
CONTACT
W
Weixia Li
CONTACT
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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