Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
- Registration Number
- NCT04879043
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 78
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HDP-101 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.
- Primary Outcome Measures
Name Time Method Number of patients who experience dose-limiting toxicity (DLT) during the first cycle of treatment - Part 1 as defined in Clinical Study Protocol Up to Day 21 (from first dose) Objective response rate (ORR) 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
Name Time Method Assess the safety and tolerability of HDP-101 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.
To assess the anticancer activity of HDP-101 in terms of time-to-event (TTE) Through study completion, an average of 1 year Clinical efficacy of HDP-101 measured by Progression Free Survival (PFS) and Overall Survival (OS).
Trial Locations
- Locations (16)
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
Mount Sinai, The Tisch Cancer Instutute
🇺🇸New York, New York, United States
Asklepios Klinik Altona, Haematologie und internistische Onkologie
🇩🇪Hamburg, Germany
Charité - Campus Benjamin Franklin Med. Klinik m.S. Hämatologie, Onkologie
🇩🇪Berlin, Germany
Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III
🇩🇪Chemnitz, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
UKSH Campus Lübeck Klinik für Hämatologie und Onkologie
🇩🇪Lübeck, Germany
Universitätsklinikum Köln
🇩🇪Köln, Germany
Pratia Onkologia Katowice
🇵🇱Katowice, Poland
Universitätsklinikum Mainz
🇩🇪Mainz, Germany
National Institute of Oncology, Department of Oncological Internal Medicine
🇭🇺Budapest, Hungary
Semmelweis University, Belgyogyaszati es Onkologiai Klinika
🇭🇺Budapest, Hungary
Szpital Wojewodzki w Opolu
🇵🇱Opole, Poland
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
🇵🇱Łódź, Poland
Universitätsklinikum Schleswig-Holstein
🇩🇪Kiel, Germany