A Phase 1/2 interventional study of HDP-101 in Multiple Myeloma and Plasma Cell Disorder, sponsored by Heidelberg Pharma AG. Recruiting at 24 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Heidelberg Pharma AG · Phase 1/2, Interventional, and Treatment
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.
Exclusion Criteria:
Participants will receive HDP-101 intravenously in a 21 day cycle until disease progression, intolerable toxicity, Investigator's discretion or patient withdrawal. During the phase 1 tolerability of different dose levels will be evaluated. During the phase 2a dose expansion part the recommended phase 2 dose (RP2D) of HDP-101 will be administered.
Drug: HDP-101
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
Plan to share: No
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Heidelberg Pharma AG