Study to Assess Safety and Efficacy of HDP-101 in Chinese Patients With Relapsed or Refractory Multiple Myeloma
Condition(s) studied
Investigational drug(s) / intervention(s)
HDP-101: HDP-101 is available as lyophilized white powder for preparation of infusion.
Study 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.
Eligibility
Primary outcome measure(s)
- Number of patients who experience a dose-limiting toxicity (DLT) during the first cycle of treatment. — Up to Day 21 (from first dose)
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Chao-Yang Hospital, Capital Medical University | Beijing | Beijing Municipality | Recruiting |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | Recruiting |
| Qilu Hospital of Shandong University | Jinan | Shandong | Recruiting |
| Institute of Hematology & Blood Diseases Hospital,Chinese Academy of Medical Sciences | Tianjin | Tianjin Municipality | Recruiting |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | Not Yet Recruiting |
More Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07529782 on ClinicalTrials.gov ↗ ← All trials in China