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A Phase 1/2a, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Patients With Plasma Cell Disorders Including Multiple Myeloma

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Trial Profile

A Phase 1/2a, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Patients With Plasma Cell Disorders Including Multiple Myeloma

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 23 Jul 2026

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At a glance

  • Drugs HDP 101 (Primary)
  • Indications Multiple myeloma
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Heidelberg Pharma AG

Most Recent Events

  • 17 Jul 2026 Planned primary completion date changed from 1 Aug 2025 to 1 Mar 2028.
  • 24 Apr 2025 According to a Heidelberg Pharma AG media release,The analysis of the data is ongoing. The presentation of new clinical data is planned for the EHA Congress, a conference of the European Hematology Association, in Milan, Italy, in mid-June.
  • 24 Apr 2025 According to a Heidelberg Pharma AG media release,The first seven patient cohorts and dose levels have been completed.The Safety Review Committee (SRC) concluded that the 112.50 µg/kg dose is safe and well tolerated and study can continue with cohort 8((140 µg/kg)) .Patients in cohort 8 will also be dosed in two different arms.As long as patients in cohort 7 do not progress, they will continue to be treated with the previous dose level.

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