Actively Recruiting
A IB/II Phase Clinical Study on the Safety, Tolerability, and Efficacy of SHR-9839(sc) in Combination Anti-tumor Therapy in Patients With Solid Tumors
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2026-03-20
70
Participants Needed
2
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an open-label, multi-center Phase IB/II clinical trial of SHR-9839(sc) combined with anti-tumor therapy in patients with advanced solid tumors, aimed at evaluating the safety, tolerability, and efficacy of SHR-9839(sc) in combination with anti-tumor therapy in patients with advanced solid tumors.
CONDITIONS
Official Title
A IB/II Phase Clinical Study on the Safety, Tolerability, and Efficacy of SHR-9839(sc) in Combination Anti-tumor Therapy in Patients With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent and comply with study visits and procedures
- Age between 18 and 70 years at consent
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- At least one measurable lesion by RECIST v1.1
- Provide tumor tissue samples or discuss alternatives with sponsor
- Major organ function within required limits without recent correction treatments
- Female subjects of reproductive potential must use effective contraception during and 9 months after treatment, avoid donating eggs, not breastfeed, and have negative pregnancy test
- Male subjects with partners of reproductive potential must use effective contraception during and 6 months after treatment and avoid donating sperm
You will not qualify if you...
- Active central nervous system metastases or leptomeningeal metastases
- Other malignancies within 3 years except certain treated cancers
- Uncontrolled tumor-related pain or unstable analgesic regimen
- Severe cardiovascular or cerebrovascular diseases
- Moderate or severe ascites or uncontrolled pleural or pericardial effusion
- History or signs of interstitial pneumonia or serious lung diseases affecting lung function
- Severe infection within 4 weeks or active infections needing systemic antibiotics within 2 weeks
- Immunodeficiency including HIV or active hepatitis B or C
- Active pulmonary tuberculosis within 1 year or untreated history
- Unrecovered adverse reactions to prior anti-tumor treatments beyond grade 1
- Anti-tumor treatments within 4 weeks prior to study
- Recent high-dose chest or non-chest radiotherapy within specified timeframes
- Major surgery within 4 weeks or minor surgery within 7 days prior to study
- Recent or unresolved intestinal obstruction or intestinal stent in place
- Severe gastrointestinal disorders grade 2 or higher except minor bleeding
- Use of live attenuated vaccines within 28 days before study or planned during study
- Pregnant or breastfeeding women or planning pregnancy during study and 7 months after
- History of severe allergic reactions to study drug components
- Other factors judged by investigator that may affect safety or study results such as severe diseases, psychiatric disorders, substance abuse, or social factors
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of Nanjing Medical University, Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
2
Fudan University Affiliated Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Z
Zhengjin Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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