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

Last updated: July 22, 2024
Sponsor: Heidelberg Pharma AG
Overall Status: Active - Recruiting

Phase

1/2

Condition

Cancer

Bone Neoplasm

Red Blood Cell Disorders

Treatment

HDP-101

Clinical Study ID

NCT04879043
HDP-101-01
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 establishedby 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 haveincluded an immunomodulatory drug, proteasome inhibitor, and anti-CD38 treatment,alone or in combination. In addition, the patient should either refractory orintolerant to any established standard of care therapy providing a meaningfulclinical benefit for the patient assessed by the Investigator.

  • Measurable disease as per IMWG criteria.

  • Adequate organ system function as defined in protocol.

Exclusion

Exclusion Criteria:

  • For patient entering the Phase 2a part only: Prior treatment with any approved orexperimental 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 planningfor autologous SCT.

  • Symptomatic graft versus host disease post allogenic hemopoietic cell transplantwithin 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 Bcore antigen.

  • Patients with positive test results for hepatitis C virus (HCV) infection.

  • Current active liver or biliary disease.

Study Design

Total Participants: 78
Treatment Group(s): 1
Primary Treatment: HDP-101
Phase: 1/2
Study Start date:
February 07, 2022
Estimated Completion Date:
May 31, 2026

Study 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.

Connect with a study center

  • Charité - Campus Benjamin Franklin Med. Klinik m.S. Hämatologie, Onkologie

    Berlin, 12203
    Germany

    Site Not Available

  • Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III

    Chemnitz, 09116
    Germany

    Active - Recruiting

  • Asklepios Klinik Altona, Haematologie und internistische Onkologie

    Hamburg, 22763
    Germany

    Active - Recruiting

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120
    Germany

    Active - Recruiting

  • Universitätsklinikum Schleswig-Holstein

    Kiel, 24105
    Germany

    Active - Recruiting

  • Universitätsklinikum Köln

    Köln, 50937
    Germany

    Active - Recruiting

  • UKSH Campus Lübeck Klinik für Hämatologie und Onkologie

    Lübeck, 23538
    Germany

    Active - Recruiting

  • Universitätsklinikum Mainz

    Mainz, 55131
    Germany

    Site Not Available

  • National Institute of Oncology, Department of Oncological Internal Medicine

    Budapest, 1122
    Hungary

    Active - Recruiting

  • Semmelweis University, Belgyogyaszati es Onkologiai Klinika

    Budapest, 1083
    Hungary

    Active - Recruiting

  • Pratia Onkologia Katowice

    Katowice, 40-519
    Poland

    Active - Recruiting

  • Szpital Wojewodzki w Opolu

    Opole, 45-061
    Poland

    Site Not Available

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

    Łódź, 93-513
    Poland

    Site Not Available

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Mount Sinai, The Tisch Cancer Instutute

    New York, New York 10029
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.