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Clinical Trial 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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT04879043
Study type Interventional
Source Heidelberg Pharma AG
Contact András Strassz, MD
Phone + 49 6203 1009 0
Email clinical@hdpharma.com
Status Recruiting
Phase Phase 1/Phase 2
Start date February 7, 2022
Completion date May 2025

See also
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