The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of HRS-3802 monotherapy in patients with malignant solid tumors.
Patients must be willing to participate in the study, sign the informed consent form, have good compliance, and cooperate with follow-up visits;
Age ≥18 years, male or female;
Patients with advanced malignant tumors confirmed pathologically;
Failure of adequate standard treatment, or no effective standard treatment;
Subjects had cancerous meningitis or untreated central nervous system metastases;
Subjects had severe cardiovascular and cerebrovascular diseases;
There is third-space effusion that cannot be controlled by drainage and other methods (such as massive ascites, pleural effusion, pericardial effusion);
Subjects had or currently had idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia , drug pneumonia, or CT during screening showed active pneumonia;
Single group
HRS-3802
DrugHRS-3802
Number of subjects with adverse events and the severity of adverse events
Dose-limiting toxicity (DLT)
Maximum tolerated dose (MTD)
Recommended Phase II Dose (RP2D)
Objective response rate (ORR) - RECIST 1.1
ORR is defined as the proportion of subjects who have achieved complete response (CR) or partial response (PR) according to RECIST 1.1.
Duration of Response (DoR) per RECIST 1.1
Progression-free survival (PFS) per RECIST 1.1
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