Phase I Study of SHR-9539 Injection to Evaluate Safety and Effectiveness in Adults With Multiple Myeloma

What this Trial Is About

Researchers are evaluating SHR-9539 Injection in patients with multiple myeloma through a multicenter, open-label Phase I trial. The study aims to assess the safety, tolerability, how the body processes the drug pharmacokinetics, its biological effects pharmacodynamics, and its potential efficacy profile. This trial is designed to better understand SHR-9539s impact on multiple myeloma, a type of blood cancer, under the sponsorship of Suzhou Suncadia Biopharmaceuticals Co., Ltd. Participants will receive SHR-9539 via injection in a dose-escalation and dose-expansion format. This means that the dosage will be carefully increased and extended to find the appropriate dose to study. The treatment period includes initial dose escalation followed by a dose expansion phase to further evaluate the drugs effects at the selected dose. During the study, participants will be monitored for safety and treatment effects for approximately 24 months. Researchers will assess the recommended phase 2 dose RP2D, record any adverse events, and measure drug concentration and timing in the body. They will also evaluate the overall response rate to the treatment. Regular assessments will include health evaluations and laboratory tests to track the participants condition and treatment response throughout the study.

A Clinical Study of SHR-9539 in Patients With Multiple Myeloma