Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHeidelberg Pharma AG
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
For patient entering the Phase 2a part only: Prior treatment with any approved or experimental BCMA-targeting modalities are not allowed.
Known central nervous system involvement.
Plasma cell leukemia.
History of congestive heart failure.
Trial design
Design model
Single group
Treatments tested in this trial
HDP-101
DrugHDP-101 is available as lyophilized white powder for preparation of infusion.
Treatment groups
78 Participants
are divided into 1 treatment groupGroup A: HDP-101Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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 yearSecondary outcomes
1
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 year2
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 yearSponsors and contacts
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Source ClinicalTrials.gov