Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
Start Date
2/7/2022
Completion Date
9/1/2028
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.
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
HDP-101
Conditions
Locations
Winship Cancer Institute of Emory University
Atlanta, Georgia 30322
United States
Norton Healthcare, Inc.
Louisville, Kentucky 40202
United States
Nebraska Cancer Institute
Omaha, Nebraska 68130
United States
Mount Sinai, The Tisch Cancer Instutute
New York, New York 10029
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
Charité - Campus Benjamin Franklin Med. Klinik m.S. Hämatologie, Onkologie
Berlin, 12203
Germany
Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III
Chemnitz, 09116
Germany
Universitätsklinikum Köln
Cologne, 50937
Germany
Asklepios Klinik Altona, Haematologie und internistische Onkologie
Hamburg, 22763
Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120
Germany
Universitätsklinikum Schleswig-Holstein
Kiel, 24105
Germany
UKSH Campus Lübeck Klinik für Hämatologie und Onkologie
Lübeck, 23538
Germany
Universitätsklinikum Mainz
Mainz, 55131
Germany
Semmelweis University, Belgyogyaszati es Onkologiai Klinika
Budapest, 1083
Hungary
National Institute of Oncology, Department of Oncological Internal Medicine
Budapest, 1122
Hungary
Pécsi Tudományegyetem Klinikai Központ
Pécs, 7624
Hungary
Pratia Onkologia Katowice
Katowice, 40-568
Poland
Pratia Onkologia Kraków
Krakow, 40-519
Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, 93-513
Poland
Szpital Wojewodzki w Opolu
Opole, 45-061
Poland
AIDPORT Sp. zo.o.
Skórzewo, 60-185
Poland
MICS Centrum Medyczne Torun
Torun, 87-100
Poland
Arensia Clinics SRL
Bucharest,
Romania
Oncology Institute Prof. Dr. Ion Chiricuta I.O.C.N.
Cluj-Napoca,
Romania