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
Who is this study for? Patients with plasma cell disorders including multiple myeloma
What treatments are being studied? HDP-101
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Georgia
Winship Cancer Institute of Emory University
RECRUITING
Atlanta
New York
Mount Sinai, The Tisch Cancer Instutute
RECRUITING
New York
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Other Locations
Germany
Charité - Campus Benjamin Franklin Med. Klinik m.S. Hämatologie, Onkologie
NOT_YET_RECRUITING
Berlin
Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III
RECRUITING
Chemnitz
Universitätsklinikum Köln
RECRUITING
Cologne
Asklepios Klinik Altona, Haematologie und internistische Onkologie
RECRUITING
Hamburg
Universitätsklinikum Heidelberg
RECRUITING
Heidelberg
Universitätsklinikum Schleswig-Holstein
RECRUITING
Kiel
UKSH Campus Lübeck Klinik für Hämatologie und Onkologie
RECRUITING
Lübeck
Universitätsklinikum Mainz
WITHDRAWN
Mainz
Hungary
National Institute of Oncology, Department of Oncological Internal Medicine
RECRUITING
Budapest
Semmelweis University, Belgyogyaszati es Onkologiai Klinika
RECRUITING
Budapest
Poland
Pratia Onkologia Katowice
RECRUITING
Katowice
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
NOT_YET_RECRUITING
Lodz
Szpital Wojewodzki w Opolu
NOT_YET_RECRUITING
Opole
Contact Information
Primary
András Strassz, MD
clinical@hdpharma.com
+ 49 6203 1009 0
Time Frame
Start Date:2022-02-07
Estimated Completion Date:2026-05
Participants
Target number of participants:78
Treatments
Experimental: 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.