Heidelberg Pharma AG, a clinical-stage biotech company developing innovative Antibody Drug Conjugates (ADCs), today announced the determination of the recommended Phase II dose (RP2D) in its Phase I/IIa study with pamlectabart tismanitin (HDP-101) for the treatment of relapsed or refractory multiple myeloma. Heidelberg Pharma’s Benefit and Risk Assessment team agreed with the recommendation by the study’s Safety Review Committee (SRC), which had conducted a comprehensive review of safety, tolerability and pharmacokinetic (PK) data from the Company’s ongoing Phase I/IIa trial.
– Phase I part of trial with pamlectabart tismanitin (HDP-101) will now be concluded as the recommended Phase II dose (RP2D) has been selected based on safety and tolerability data
– Initiation of Phase IIa in Multiple Myeloma planned in the next few weeks
– Further details will be published at a future scientific conference