Actively Recruiting
A Multicenter, Open-label, Phase II Clinical Study of SHR-4849 Injection Combined With Other Antineoplastic Drugs in Patients With Malignant Solid Tumors
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2026-03-03
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of SHR-4849 injection combined with other antitumor drugs in adults with malignant solid tumors. This phase II clinical study is led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. and aims to assess how well this combination treatment works and how safe it is for patients with this condition. Participants will receive SHR-4849 combined with other drugs such as SHR-1316, SHR-8068, BP102, carboplatin, and cisplatin. The study is open-label and multicenter, meaning both patients and researchers know which treatment is given. The trial includes two stages the first stage focuses on safety and tolerability over up to 21 days and safety follow-up for up to 24 months, while the second stage evaluates the treatments effectiveness over 24 months. During the study, participants will be closely monitored for side effects, treatment response, and overall health. Researchers will track adverse events according to specific criteria and measure outcomes like tumor response rate, duration of response, disease control, progression-free survival, and overall survival for up to 30 months. Safety follow-up continues through the study period to ensure participant well-being throughout their involvement.
CONDITIONS
Brief Title
A Trial of SHR-4849 Combined With Other Antitumor Drugs in Patients With Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject has provided informed consent before starting any study procedures
- Aged between 18 and 75 years at the time of consent
- Histologically or cytologically confirmed solid tumors
- At least one measurable lesion identified per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Life expectancy of at least 3 months
- Adequate organ function
- Participants of child-bearing potential must use highly effective contraception from consent until 8 months after last dose
You will not qualify if you...
- Active central nervous system (CNS) metastasis
- History of malignant tumors within 5 years prior to first dose
- Uncontrolled cancer pain
- Severe cardiovascular disease
- Clinically significant hemorrhage
- Uncontrolled pleural, peritoneal, or pericardial effusion
- Suspected interstitial lung disease
- Serious infection within 4 weeks prior to first dose
- Known history of HIV, active hepatitis B or C infection
- Previous adverse events from antineoplastic therapy not recovered to grade 1 or less
- Anti-cancer treatment within 4 weeks prior to first dose
- Major surgery within 4 weeks prior to first dose
- Planned or received live vaccines within 28 days prior to first dose
- Pregnant, lactating, or planning pregnancy during study period
- Allergy to any investigational drug component
- Alcohol or drug abuse or other serious medical conditions affecting safety or data
- Other conditions per investigator judgment that may affect results or procedures
Research Team
W
Wei Hou
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