Actively Recruiting
A Phase IB/II Clinical Study of SHR-9839 for Injection Combined With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors
Led by Shanghai Hengrui Pharmaceutical Co., Ltd. · Updated on 2026-05-11
156
Participants Needed
2
Research Sites
282 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability and efficacy of SHR-9839 for injection in combination with other antitumor therapies in patients with advanced solid tumors.
CONDITIONS
Official Title
A Phase IB/II Clinical Study of SHR-9839 for Injection Combined With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-75 years old (inclusive), regardless of gender.
- Part A: Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology.
- Part B: Patients with squamous non-small cell lung cancer.
- At least one measurable tumor lesion according to RECIST v1.1.
- ECOG performance score of 0-1.
- Life expectancy of 12 weeks or more.
- Adequate bone marrow and organ function.
- Ability to give informed consent and willingness to comply with study procedures.
You will not qualify if you...
- Active central nervous system metastases.
- Spinal cord compression not curable by surgery or radiotherapy.
- Uncontrollable tumor-related pain.
- Moderate or severe ascites with symptoms; moderate or worse pleural or pericardial effusion that is uncontrollable.
- Chemotherapy within 4 weeks before the first dose of study drug.
- Chest radiotherapy over 30 Gy within 24 weeks before the first dose of study drug.
- Major organ surgery or significant trauma within 4 weeks before the first dose of study drug.
- Other malignancies within 3 years before the first dose of study drug.
- History or evidence of interstitial pneumonitis or other moderate to severe lung disease affecting lung function.
- Serious cardiovascular or cerebrovascular diseases.
- Clinically significant bleeding within 3 months before the first dose of study drug.
- History of immunodeficiency including HIV positive.
- Active hepatitis B or C infection.
- Severe allergic reactions to any study drug components.
- Known history of alcohol or drug dependence.
- Mental disorders or poor compliance.
- Pregnant or lactating women.
- Active, known, or suspected autoimmune disease.
- Systemic immunostimulatory therapy within 4 weeks before the study or systemic immunosuppressive therapy within 2 weeks before the first dose.
- Previous immune checkpoint inhibitor use with severe immune-related adverse events lasting 4 weeks or more or grade 4 adverse events.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
2
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310005
Actively Recruiting
Research Team
Q
Qingkai Zhou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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