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.
Able to provide informed consent, has signed the IRB/EC-approved informed consent form with the date indicated, and is willing and able to comply with treatment plan visits, examinations, and other procedural requirements;
Age 18-70 years (inclusive) at the time of signing the informed consent form, no gender restriction;
ECOG performance status of 0 or 1;
Expected survival ≥12 weeks;
Patients with active central nervous system (CNS) metastases or leptomeningeal metastases (including a history of such);
Patients with other malignancies within 3 years before the first dose, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, locally resected prostate cancer, ductal carcinoma in situ post-surgery, or papillary thyroid carcinoma post-surgery (hormonal therapy for non-metastatic prostate or breast cancer is allowed);
Patients deemed by the investigator to have uncontrolled tumor-related pain. Subjects requiring analgesic treatment must have a stable analgesic regimen before entering the study; symptomatic lesions suitable for palliative radiotherapy should be treated prior to study entry;
Patients with severe cardiovascular or cerebrovascular disease;
Single group
SHR-9839(sc) For Injection
DrugSHR-9839(sc) for injection.
Dose-limiting toxicities (DLT)
Adverse events (AEs)
Recommended dose for expansion (RDE)
Phase II.
Objective Response Rate (ORR)
Disease control rate (DCR)
Duration of response (DoR)
Progression-Free Survival (PFS)
Overall Survival (OS)
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