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RECRUITING
NCT07529782
PHASE1

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.

View on ClinicalTrials.gov

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

DRUG

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