This is an open label, multi-center, Phase Ib/II study to evaluate the safety, tolerability and efficacy of SHR-4375 injection in combination with other antitumor therapies in patients with advanced solid tumors.
Voluntary participation and written informed consent.
18-75 years older, no gender limitation.
Eastern Cooperative Oncology Group (ECOG) score: 0-1.
With a life expectancy ≥ 12 weeks.
There are components of neuroendocrine carcinoma or sarcoma in the histopathological type.
Had received chemotherapy, immunotherapy, targeted therapy, anti-tumor traditional Chinese medicine or other clinical research drugs within 4 weeks prior to the first administration of the study; Palliative radiotherapy was received within 2 weeks before the first administration.
Live attenuated vaccines are used within a certain period of time before the first medication as stipulated in the plan, or it is expected that such vaccines will be needed during the treatment period.
Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration.
Single group
SHR-4375 Injection
DrugSHR-4375 injection in combination with other antitumor therapies.
Dose limiting toxicity (DLT).
Recommended phase II dose (RP2D).
Adverse events (AEs).
Objective response rate (ORR).
Disease control rate (DCR)
Duration of response (DoR)
Progression-free survival (PFS)
Drug Resistant Antibody (ADA) to SHR-4375
Immunogenicity: The number of subjects with ADA to SHR-4375, incidence, time of occurrence, duration, etc.
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