Actively Recruiting
A Single-arm, Open-Label, Multi-center Phase I 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and how the body processes HRS-3802 when used alone in patients with advanced malignant solid tumors. This phase I clinical study aims to better understand these factors in patients whose tumors have either not responded to standard treatments or for whom no effective standard treatments exist. The study is sponsored by Shandong Suncadia Medicine Co., Ltd. Participants will receive HRS-3802 as a single treatment. The study is open-label, meaning both participants and researchers know the treatment being given. The research includes monitoring for side effects and determining the maximum tolerated dose and recommended dose for future studies. Treatment effects will be assessed over several months, with follow-up evaluations up to two years for progression and response. During the study, participants will be monitored regularly for adverse events, dose-related toxicities, and tumor response using RECIST 1.1 criteria. Safety assessments will occur every four weeks, especially during the first 28 days of treatment. Researchers will also evaluate outcomes such as objective response rate, duration of response, and progression-free survival. Participants are expected to survive at least 12 weeks and will be followed for up to two years to assess treatment impact and safety.
CONDITIONS
Brief 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 must agree to participate, sign informed consent, comply with study visits, and cooperate with follow-up
- Age 18 years or older, male or female
- Pathologically confirmed advanced malignant tumors
- Failure of adequate standard treatment or no effective standard treatment available
- At least one measurable extracranial target lesion per RECIST v1.1
- Expected survival longer than 12 weeks
- ECOG physical fitness score of 0 or 1
- Adequate bone marrow and organ function without recent blood transfusion or hematopoietic factor treatment within 14 days
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before starting treatment and agree to use effective contraception during and for 1 month after treatment
You will not qualify if you...
- Cancerous meningitis or untreated central nervous system metastases
- Severe cardiovascular or cerebrovascular diseases
- Uncontrolled third-space effusion such as large ascites, pleural, or pericardial effusion
- History or current diagnosis of idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation or drug-induced pneumonia, or active pneumonia on CT
- Arteriovenous thrombosis within 6 months before first dose
- Severe infection within 4 weeks before treatment
- 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-tumor therapies during the study
- Known allergies or contraindications to the study drug or its components
- Other serious conditions or social factors that may affect safety or study participation as judged by the investigator
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 28-day cycles until disease progression or discontinuation
Participants receive HRS-3802 monotherapy to evaluate safety, tolerability, and pharmacokinetics.
Visits every 4 weeks during treatment
Duration - Up to approximately 2 years
Participants are monitored for response duration and progression-free survival up to approximately 2 years after treatment.
Visits scheduled as per study protocol for monitoring
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
Y
Yueling Wang
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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