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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

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: 19 Mar 2024

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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

    • 18 Mar 2024 According to a Heidelberg Pharma AG media release, further data readouts will be reported at upcoming scientific conferences in 2024.
    • 18 Mar 2024 According to a Heidelberg Pharma AG media release, company submitted a protocol amendment to the FDA in February 2024 allowing planned modification and optimization of the medication regimen to lessen the initial transient and reversible reduction of thrombocyte count. Upon ethics committee approval patients will be enrolled in Cohort 6.
    • 18 Mar 2024 According to a Heidelberg Pharma AG media release, company announced that it will be advancing into an expanded Cohort 6 dose escalation following submission of a protocol amendment to the US Food and Drug Administration (FDA) for its Phase I/IIa study with lead ATAC candidate HDP-101 for the treatment of multiple myeloma.
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