This study aims to evaluate the safety, tolerability and efficacy of SHR-7787 in combination with other anti-tumor drugs in patients with malignant solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
SHR-7787 Injection.
SHR-1316 Injection.
SHR-4849 Injection.
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
RECRUITINGShanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGThe Recommended phase II dose of SHR-7787 injection monotherapy (stage I)
Time frame: Expected to be two years after the start of the study.
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (stage I)
Time frame: About 1 year after study initiation.
Incidence and severity of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (stage I)
Time frame: About 1 year after study initiation.
Incidence of Dose Limited Toxicity (DLT) described in the protocol (stage I)
Time frame: About 1 year after study initiation.
Objective response rate (ORR) (stage II)
Time frame: Expected to be two years after the start of the study.
Progress Free Survival (FPS) (stage II)
Time frame: Expected to be two years after the start of the study.
Objective response rate (ORR)
Time frame: About 1 year.
Duration of Response (DoR)
Time frame: About 1 year.
Disease Control Rate (DCR)
Time frame: About 1 year.
Progress Free Survival (PFS)
Time frame: About 1 year.
Overall Survival (OS)
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Etoposide Injection.
Carboplatin Injection.
Cisplatin Injection.
BP102 Injection.
Time frame: About 1 year.