Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma

Active:	Yes
Cancer Type:	Multiple Myeloma	NCT ID:	NCT04879043
Trial Phases:	Phase I Phase II	Protocol IDs:	HDP-101-01 (primary) NCI-2021-04304
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Heidelberg Pharma AG
NCI Full Details:	http://clinicaltrials.gov/show/NCT04879043

Summary

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.

Objectives

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.

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