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

H

Heidelberg Pharma

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Multiple Myeloma
Plasma Cell Disorder

Treatments

Drug: HDP-101

Study type

Interventional

Funder types

Industry

Identifiers

NCT04879043
HDP-101-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

78 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female aged ≥18 years.
  • Life expectancy >12 weeks.
  • Eastern Cooperative Oncology Group Performance Status (PS) of 0 to 2.
  • A confirmed diagnosis of active MM according to the diagnostic criteria established by the International Myeloma Working Group (IMWG).
  • Must have undergone SCT or is considered transplant ineligible.
  • Must have undergone prior treatments with antimyeloma therapy which must have included an immunomodulatory drug, proteasome inhibitor, and anti-CD38 treatment, alone or in combination. In addition, the patient should either refractory or intolerant to any established standard of care therapy providing a meaningful clinical benefit for the patient assessed by the Investigator.
  • Measurable disease as per IMWG criteria.
  • Adequate organ system function as defined in protocol.

Exclusion criteria

  • For patient entering the Phase 2a part only: Prior treatment with any approved or experimental BCMA-targeting modalities are not allowed.
  • Known central nervous system involvement.
  • Plasma cell leukemia.
  • History of congestive heart failure.
  • Autologous or allogenic SCT within 12 weeks before the first infusion or is planning for autologous SCT.
  • Symptomatic graft versus host disease post allogenic hemopoietic cell transplant within 12 months prior to the first study treatment infusion.
  • Radiotherapy within 21 days prior to the first study treatment infusion.
  • History of any other malignancy known to be active.
  • Known human immunodeficiency virus infection.
  • Patients with active infection requiring systemic anti-infective.
  • Patients with positive test results for hepatitis B surface antigen or Hepatitis B core antigen.
  • Patients with positive test results for hepatitis C virus (HCV) infection.
  • Current active liver or biliary disease.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

78 participants in 1 patient group

HDP-101
Experimental group
Description:
Participants will receive HDP-101 intravenously in a 21 day cycle until disease progression, intolerable toxicity, Investigator's discretion or patient withdrawal. During the phase 1 tolerability of different dose levels will be evaluated. During the phase 2a dose expansion part the recommended phase 2 dose (RP2D) of HDP-101 will be administered.
Treatment:
Drug: HDP-101

Trial contacts and locations

16

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Central trial contact

András Strassz, MD

Data sourced from clinicaltrials.gov

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