This study will assess the safety, tolerability, pharmacokinetics (PK) and the therapeutic potential of HDP-101 in patients with plasma cell disorders including multiple myeloma.
The study will consists of two parts: a Part 1 dose escalation phase and a Part 2a expansion phase for safety, tolerability, PK, PD, and clinical activity testing. The study will enroll subjects with relapsed/refractory MM or other plasma cell disorders expressing BCMA. An adaptive 2-parameter Bayesian logistic regression model (BLRM) for dose-escalation with overdose control will be used in the dose-escalation phase for determination of the MTD or the RP2D. Dose-expansion phase of the study aims to collect preliminary evidence of antitumor activity and to confirm the safety of the HDP-101 as a monotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
78
HDP-101 is available as lyophilized white powder for preparation of infusion.
Number of patients who experience dose-limiting toxicity (DLT) during the first cycle of treatment - Part 1 as defined in Clinical Study Protocol
Time frame: Up to Day 21 (from first dose)
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.
Time frame: Through study completion, an average of 1 year
Assess the safety and tolerability of HDP-101
Number of patients with serious and non-serious adverse events grouped by system organ class and preferred terms based on Common Terminology Criteria for Adverse Events (CTCAE v 5.0) classification.
Time frame: Through study completion, an average of 1 year
To assess the anticancer activity of HDP-101 in terms of time-to-event (TTE)
Clinical efficacy of HDP-101 measured by Progression Free Survival (PFS) and Overall Survival (OS).
Time frame: Through study completion, an average of 1 year
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Atlanta, Georgia, United States
Norton Healthcare, Inc.
Louisville, Kentucky, United States
NOT_YET_RECRUITINGNebraska Cancer Institute
Omaha, Nebraska, United States
RECRUITINGMount Sinai, The Tisch Cancer Instutute
New York, New York, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGCharité - Campus Benjamin Franklin Med. Klinik m.S. Hämatologie, Onkologie
Berlin, Germany
WITHDRAWNKlinikum Chemnitz gGmbH, Klinik f. Innere Medizin III
Chemnitz, Germany
WITHDRAWNUniversitätsklinikum Köln
Cologne, Germany
WITHDRAWNAsklepios Klinik Altona, Haematologie und internistische Onkologie
Hamburg, Germany
WITHDRAWNUniversitätsklinikum Heidelberg
Heidelberg, Germany
ACTIVE_NOT_RECRUITING...and 14 more locations