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

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ClinicalTrials.gov Identifier: NCT04879043
Recruitment Status : Not yet recruiting
First Posted : May 10, 2021
Last Update Posted : May 10, 2021
Sponsor:
Information provided by (Responsible Party):
Heidelberg Pharma AG

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Plasma Cell Disorder Drug: HDP-101 Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Eligible patients will be enrolled and treated with intravenous HDP-101 every 3 weeks.

A Bayesian logistic regression model will be used to guide dose-escalation during Phase 1 and select the best dose for the Phase 2a of the study.

Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: HDP-101

Participants 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.

Drug: HDP-101
HDP-101 is available as lyophilized white powder for preparation of infusion.




Primary Outcome Measures :
  1. 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) ]
  2. Objective response rate (ORR) [ Time Frame: Through study completion, an average of 1 year ]
    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 :
  1. Assess the safety and tolerability of HDP-101 [ Time Frame: Through study completion, an average of 1 year ]
    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.

  2. 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 ]
    Clinical efficacy of HDP-101 measured by Progression Free Survival (PFS) and Overall Survival (OS).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04879043


Contacts
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Contact: András Strassz, MD + 49 6203 1009 0 clinical@hdpharma.com

Locations
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United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, New York
Mount Sinai, The Tisch Cancer Instutute
New York, New York, United States, 10029
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg Pharma AG
Additional Information:
Publications:
Strassz A, Raab MS, Orlowski RZ, Kulke M, Schiedner G, Pahl A. A First in Human Study Planned to Evaluate HDP-101, an Anti-BCMA Amanitin Antibody-Drug Conjugate with a New Payload and a New Mode of Action, in Multiple Myeloma. Blood 2020; 136 (Supplement 1): 34. doi: https://doi.org/10.1182/blood-2020-142285

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Responsible Party: Heidelberg Pharma AG
ClinicalTrials.gov Identifier: NCT04879043    
Other Study ID Numbers: HDP-101-01
First Posted: May 10, 2021    Key Record Dates
Last Update Posted: May 10, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Paraproteinemias
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases