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

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 confir

Trial Details

NCT ID
NCT07529782
Phase
PHASE1
Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Status
RECRUITING
Cancer Type
Relapsed/Refractory Multiple Myeloma
Interventions
  • HDP-101
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Suzhou, Jiangsu, China|31.30408,120.59538
  • Jinan, Shandong, China|36.66833,116.99722
  • Tianjin, Tianjin Municipality, China|39.14222,117.17667
  • Hangzhou, Zhejiang, China|30.29365,120.16142

Key Eligibility Criteria

  • Male or female aged ≥18 years.
  • Life expectancy \>12 weeks.
  • Eastern Cooperative Oncology Group Performance Status (PS) of 0 to 2.
  • A confirmed diagnosis of active MM according to the diagnostic criteria established by the International Myeloma Working Group (IMWG).

For full eligibility, visit ClinicalTrials.gov.

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