A Study of SHR-A1909 in Subjects With Advanced Malignant Tumors

A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-1909 Injection in Patients With Advanced Malignant Tumors

This is an, open-label, multi-center, three-part phase I trial to evaluate the safety, pharmacokinetics and immunogenicity of SHR-1909 and preliminary anti-tumor efficacy of SHR-1909 in advanced malignant cancer.

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Patients must have cytologically or histologically confirmed advanced malignant tumor, and must have failed standard treatment;
• Toxicities caused by prior anti-tumor treatments must have resolved to CTCAE Grade ≤ 1 prior to the first dose (except for alopecia or hypothyroidism treated with hormone replacement therapy or diabetes controlled with insulin);
• Adequate organ function.

Exclusion Criteria:

• With CNS infiltration, or ascites requiring paracentesis or symptomatic pleural effusion;
• Received prior CAR T-cell therapy;
• Received allogeneic hematopoietic stem cell transplantation within 3 months prior to the start of study treatment, or with acute/chronic graft versus host disease;
• With active infection or fever of unknown origin (> 38.5 °C).