Phase I Open-Label Study of SHR-5421 Injection Evaluating Safety and Preliminary Effects in Patients With Multiple Myeloma

What this Trial Is About

Researchers are conducting a Phase I, open-label, multicenter study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary effectiveness of SHR-5421 in patients diagnosed with multiple myeloma. The study focuses on patients whose disease has relapsed or is refractory to recent therapies, aiming to find the appropriate dose for future research. Participants will receive SHR-5421 through multiple doses as part of the experimental treatment group. The study does not involve a placebo or comparison group and follows a sequential design. The treatment period and dosing schedules are organized to evaluate the drugs properties and initial response in this patient population. During the study, participants will be monitored closely with assessments of safety including adverse events, drug concentration levels in the blood, and response rates measured by disease markers. The trial requires participants to comply with study procedures and contraception guidelines. The total study duration includes up to 24 months for outcome evaluations and follow-up to determine the recommended Phase II dose and observe effects.

A Clinical Study of SHR-5421 in Patients With Multiple Myeloma