The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-7787 injection monotherapy for patients with advanced solid tumors. To explore the reasonable dosage of SHR-7787 injection monotherapy for patients with advanced solid tumors.
Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
Patients with unresectable recurrent or metastatic solid tumors;
There is at least one lesion could be measured;
An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
Patients with known active central nervous system (CNS) metastases;
Subjects who had other malignancy in five years before the first dose;
Patients with tumor-related pain that cannot be controlled as determined;
Patients with serious cardiovascular and cerebrovascular diseases;
Single group
SHR-7787 injection
DrugFirstly Dose Escalation and Dose Expansion of SHR-7787 injection monotherapy should be conducted.
Maximum tolerated dose
The Maximum tolerated dose of SHR-7787 injection monotherapy
Recommended phase II dose
The Recommended phase II dose of SHR-7787 injection monotherapy
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Incidence of Dose Limited Toxicity (DLT)
Incidence of Dose Limited Toxicity (DLT) described in the protocol
Tmax
PK parameters of single dose of SHR-7787 injection monotherapy
Cmax
PK parameters of single dose of SHR-7787 injection monotherapy
AUC0-t
PK parameters of single dose of SHR-7787 injection monotherapy
t1/2
PK parameters of single dose of SHR-7787 injection monotherapy
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