Clinical Trials /

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

NCT04879043

Description:

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.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT04879043

Trial Eligibility

Document

Title

  • Brief Title: Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: HDP-101-01
  • NCT ID: NCT04879043

Conditions

  • Multiple Myeloma
  • Plasma Cell Disorder

Interventions

DrugSynonymsArms
HDP-101HDP-101

Purpose

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.

Detailed 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.

Trial Arms

NameTypeDescriptionInterventions
HDP-101ExperimentalParticipants will receive HDP-101 intravenously at one dose every 3 weeks (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.
  • HDP-101

Eligibility Criteria

        Inclusion Criteria:

          -  Male or female aged ≥18 years.

          -  Life expectancy >12 weeks.

          -  Eastern Cooperative Oncology Group Performance Status (PS) of 0 to 1.

          -  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.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of patients who experience dose-limiting toxicity (DLT) during the first cycle of treatment - Part 1 as defined in Clinical Study Protocol
Time Frame:Up to Day 21 (from first dose)
Safety Issue:
Description:Proportion of enrolled subjects who achieve a partial response (PR) or better, i.e. stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and PR, according to the IMWG criteria.

Secondary Outcome Measures

Measure:Assess the safety and tolerability of HDP-101
Time Frame:Through study completion, an average of 1 year
Safety Issue:
Description:Number of patients with serious and non-serious adverse events grouped by system organ class and preferred terms based on Common Terminology Criteria for Adverse Events (CTCAE v 5.0) classification.
Measure:To assess the anticancer activity of HDP-101 in terms of time-to-event (TTE)
Time Frame:Through study completion, an average of 1 year
Safety Issue:
Description:Clinical efficacy of HDP-101 measured by Progression Free Survival (PFS) and Overall Survival (OS).

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Heidelberg Pharma AG

Last Updated

May 10, 2021