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
Heidelberg Pharma AG
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 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 i…
Interventions
- DrugHDP-101
HDP-101 is available as lyophilized white powder for preparation of infusion.
Locations (16)
- Winship Cancer Institute of Emory UniversityAtlanta, Georgia
- Mount Sinai, The Tisch Cancer InstututeNew York, New York
- MD Anderson Cancer CenterHouston, Texas
- Charité - Campus Benjamin Franklin Med. Klinik m.S. Hämatologie, OnkologieBerlin
- Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin IIIChemnitz
- Universitätsklinikum KölnCologne