The study is being conducted to evaluate the efficacy and safety of HRS-4508 in subjects with advanced or metastatic solid tumors and explore the reasonable dosage of HRS-4508.
Patients must be willing to participate in the study, sign the informed consent form, have good compliance, and cooperate with follow-up visits.
Aged 18-75 years, male or female.
Patients with advanced malignant tumors confirmed pathologically;
Failure of adequate standard treatment, or no effective standard treatment;
Subjects with a history of malignant tumors, except patients with cutaneous basal cell carcinoma, superficial bladder cancer, cutaneous squamous cell carcinoma or cervical carcinoma in situ who have undergone possible curative treatment and did not have disease recurrence within 3 years since starting the 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).
Single group
HRS-4508
DrugHRS-4508
Safety endpoints: Number of subjects with adverse events and the severity of adverse events
DLT (Dose-limiting toxicity)
MTD (Maximum tolerated dose)
RP2D (Recommended Phase II Dose)
ORR (Objective response rate - 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.
DoR (Duration of Response per RECIST 1.1)
DCR (Disease control rate-RECIST 1.1)
DCR is defined as the proportion of subjects who have achieved stable disease(SD)、complete response (CR) or partial response (PR) according to RECIST 1.1.
PFS
Progression-free survival per RECIST 1.1
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