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.
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).
Known central nervous system involvement.
Plasma cell leukemia.
History of congestive heart failure.
Autologous or allogenic SCT within 12 weeks before the first infusion or is planning for autologous SCT.
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Lead sponsor
Heidelberg Pharma AG
Collaborator