Status:
NOT_YET_RECRUITING
A Study of SHR-9803 for Injection in Patients With Advanced Solid Tumors
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open label, multi-center, multiple doses Phase I/II study to evaluate the safety, tolerability ,pharmacokinetics and efficacy of SHR-9803 for injection in subjects with advanced solid tumor...
Eligibility Criteria
Inclusion
- Voluntary participation and written informed consent.
- 18-75 years old, no gender limitation.
- Eastern Cooperative Oncology Group (ECOG) score: 0-1
- With a life expectancy ≥ 3 months.
- Pathologically diagnosed advanced solid tumor.
- At least one measurable lesion according to RECIST v1.1.
- Adequate bone marrow reserve and organ function.
- Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.
Exclusion
- Have untreated central nervous system metastasis; or have meningeal metastasis or spinal cord compression;
- Uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
- Previous or co-existing malignancies；
- Severe bone damage caused by bone metastasis， including uncontrolled tumor-related pain;
- Have active or prior documented autoimmune disease;
- Have used corticosteroids (\> 10 mg/day of prednisone or equivalent) or other immunosuppressive agents for systemic treatment within 2 weeks;
- With poorly controlled or severe cardiovascular disease;
- A history of interstitial pneumonia/non-infectious pneumonia;
- Severe infection 1 month before the first dose;
- Active hepatitis B or hepatitis C, or with a history of immunodeficiency;
- With a history of inflammatory bowel disease, or those who have experienced intestinal obstruction or gastrointestinal perforation within 3 months prior to the first dose;
- Have received more than 30 Gy of pulmonary radiation therapy within 6 months prior to the first dose; Have received major surgery，Systemic chemotherapy, endocrine therapy, monoclonal antibody therapy, macromolecular targeted therapy or other investigational products within 4 weeks; or palliative radiotherapy within 2 weeks; or oral small-molecule targeted drugs within five half-lives;
- Have not recovered from the toxicities and/or complications of previous interventions to NCI-CTCAE Grade ≤ 1;
- Received live-attenuated vaccines within 4 weeks prior to the first dose.
- Known to have had an allergic reaction to other monoclonal antibodies.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06906731
Start Date
April 1 2025
End Date
December 1 2027
Last Update
April 2 2025
Active Locations (1)
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1
Harbin Medical University cancer hospital
Harbin, Heilongjiang, China, 150081