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.
Single group
HDP-101
DrugHDP-101 is available as lyophilized white powder for preparation of infusion.
Number of patients who experience a dose-limiting toxicity (DLT) during the first cycle of treatment.
Number of patients with serious and non-serious adverse events
Incidence and grading of adverse events (AEs) and serious adverse events (SAEs) (based on the National Cancer Institute's Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0). Incidence of treatment interruption and dose adjustment due to AEs and changes in laboratory tests, vital signs, physical examination and electrocardiogram (ECG).
Objective response rate (ORR)
Proportion of enrolled subjects who achieve a partial response (PR) or better, i.e. stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and PR, according to the IMWG criteria.
Minimal residual disease (MRD) negativity rate
Proportion of enrolled subjects who achieve minimal residual disease (MRD) free status, according to the IMWG criteria.
Progression-free survival (PFS)
PFS is defined as the interval from the start of study therapy to the earlier of the first documentation of disease progression/relapse or death from any cause, whichever occurs first as determined by the investigator
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Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Lead sponsor
Heidelberg Pharma AG
Collaborator
