The study is being conducted to evaluate the safety and tolerability of SHR-4506 Injection in patients with malignant tumors and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD).
Age ≥18 years, any gender.
ECOG performance status 0-1.
Histologically or cytologically confirmed malignant tumor patients who have failed standard therapy, or are intolerant to standard therapy, or have no standard treatment available.
Adequate organ function.
Prior treatment with the same class of investigational drug.
Confirmed or suspected central nervous system (CNS) tumor involvement.
Uncontrolled tumor-related pain.
Active autoimmune disease, history of immunodeficiency (including primary or secondary, e.g., HIV infection), or autoimmune disorders requiring systemic therapy.
Single group
SHR-4506 Injection
DrugSHR-4506 injection.
Dose Limited Toxicities (DLTs)
Maximum Tolerated Dose (MTD)
Incidence and severity of adverse events (AEs)
Incidence and severity of serious adverse events (SAEs)
Objective response rate (ORR) assessed by the investigator
Objective tumor response duration (DoR)
Disease control rate (DCR)
Progression free survival (PFS)
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