Actively Recruiting
A Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HRS-3802 Monotherapy in Patients With Malignant Solid Tumors
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-03-30
100
Participants Needed
6
Research Sites
201 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of HRS-3802 monotherapy in patients with malignant solid tumors.
CONDITIONS
Official Title
A Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HRS-3802 Monotherapy in Patients With Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients willing to participate, sign informed consent, comply with study, and attend follow-up visits
- Age 18 years or older, any gender
- Confirmed advanced malignant tumors by pathology
- Failure of or no effective standard treatments
- At least one measurable extracranial target lesion per RECIST v1.1
- Expected survival greater than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate bone marrow and organ function without recent blood transfusion or stimulating factor treatment within 14 days
- Female participants of childbearing potential must have a negative serum pregnancy test within 7 days before starting and agree to use effective contraception during the study and for one month after last dose
You will not qualify if you...
- Cancerous meningitis or untreated central nervous system metastases
- Severe cardiovascular or cerebrovascular diseases
- Uncontrolled third-space effusions like massive ascites, pleural or pericardial effusion
- Current or past idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation or drug-induced pneumonia, or active pneumonia seen on screening CT
- Arteriovenous thrombosis within 6 months before first dose
- Severe infection within 4 weeks before first dose
- Refractory nausea, vomiting, or gastrointestinal disorders affecting oral medication use, including malabsorption syndrome
- Known HIV infection or AIDS
- Active hepatitis
- Scheduled to receive other systemic anti-cancer therapies during the study
- Known allergies or contraindications to the investigational drug or its components
- Other conditions judged by the investigator that may affect safety or study data collection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
GenesisCare North Shore (Oncology)
Saint Leonards, New South Wales, Australia, 2065
Active, Not Recruiting
2
Macquarie University Hospital
Sydney, New South Wales, Australia, 2109
Active, Not Recruiting
3
John Flynn Private Hospital
Tugun, Queensland, Australia, 4224
Active, Not Recruiting
4
GenesisCare St Andrews
Adelaide, South Australia, Australia, 5000
Active, Not Recruiting
5
Peninsula and South Eastern Haematology & Oncology Group
Frankston, Victoria, Australia, 3199
Active, Not Recruiting
6
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
X
Xiaoyu Zhu
CONTACT
Y
Yueling Wang
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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