Clinical Trial

Study to Assess Safety and Efficacy of HDP-101 in Chinese Patients With Relapsed or Refractory Multiple Myeloma

Recruiting Phase 1
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Record status
This record was last updated April 14, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07529782
Lead Sponsor Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Collaborators: Heidelberg Pharma AG
Conditions Multiple Myeloma and Other Plasma Cell Neoplasms
Enrollment 15 participants
Start Date 2026-03-17
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-14