Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
NCT ID: NCT04879043
Last Updated: 2024-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
78 participants
INTERVENTIONAL
2022-02-07
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
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.
TREATMENT
NONE
Study Groups
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HDP-101
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.
HDP-101
HDP-101 is available as lyophilized white powder for preparation of infusion.
Interventions
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HDP-101
HDP-101 is available as lyophilized white powder for preparation of infusion.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Heidelberg Pharma AG
INDUSTRY
Responsible Party
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Locations
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Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Mount Sinai, The Tisch Cancer Instutute
New York, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
Charité - Campus Benjamin Franklin Med. Klinik m.S. Hämatologie, Onkologie
Berlin, , Germany
Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III
Chemnitz, , Germany
Universitätsklinikum Köln
Cologne, , Germany
Asklepios Klinik Altona, Haematologie und internistische Onkologie
Hamburg, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universitätsklinikum Schleswig-Holstein
Kiel, , Germany
UKSH Campus Lübeck Klinik für Hämatologie und Onkologie
Lübeck, , Germany
Universitätsklinikum Mainz
Mainz, , Germany
Semmelweis University, Belgyogyaszati es Onkologiai Klinika
Budapest, , Hungary
National Institute of Oncology, Department of Oncological Internal Medicine
Budapest, , Hungary
Pratia Onkologia Katowice
Katowice, , Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, , Poland
Szpital Wojewodzki w Opolu
Opole, , Poland
Countries
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Central Contacts
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References
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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
Other Identifiers
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HDP-101-01
Identifier Type: -
Identifier Source: org_study_id
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