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Study to Assess Safety and Efficacy of HDP-101 in Chinese Patients With Relapsed or Refractory Multiple Myeloma
Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Summary
This study is a 2-part study with a dose-escalation part and a dose-expansion part. The aim of the dose-escalation part is to determine the maximum tolerated dose (MTD) and/or establish the recommended Phase 2 dose (RP2D) in the Chinese population, in order to select the treatment dose for the dose-expansion part. The dose-escalation part will be followed by the dose-expansion part once the MTD(s) and/or RP2D of HDP-101 monotherapy in the Chinese population have been determined. The dose-expansion part of the study is intended to collect preliminary evidence of antitumor activity and to confirm the safety of the HDP-101 as monotherapy in Chinese patients with r/r MM.
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Chinese Patients With Plasma Cell Disorders Including Multiple Myeloma
Key Details
Gender
All
Age Range
Any - 18 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2026-03-17
Completion Date
2026-12-31
Last Updated
2026-04-14
Healthy Volunteers
No
Interventions
HDP-101
HDP-101 is available as lyophilized white powder for preparation of infusion.
Locations (5)
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Institute of Hematology & Blood Diseases Hospital,Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China