Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: HDP-101 Participants will receive HDP-101 intravenously at one dose every 3 weeks (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. |
Drug: HDP-101
HDP-101 is available as lyophilized white powder for preparation of infusion.
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Outcome Measures
Primary Outcome Measures
- 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
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female aged ≥18 years.
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Life expectancy >12 weeks.
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Eastern Cooperative Oncology Group Performance Status (PS) of 0 to 1.
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A confirmed diagnosis of active MM according to the diagnostic criteria established by the International Myeloma Working Group (IMWG).
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Must have undergone SCT or is considered transplant ineligible.
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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.
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Measurable disease as per IMWG criteria.
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Adequate organ system function as defined in protocol.
Exclusion Criteria:
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For patient entering the Phase 2a part only: Prior treatment with any approved or experimental BCMA-targeting modalities are not allowed.
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Known central nervous system involvement.
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Plasma cell leukemia.
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History of congestive heart failure.
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Autologous or allogenic SCT within 12 weeks before the first infusion or is planning for autologous SCT.
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Symptomatic graft versus host disease post allogenic hemopoietic cell transplant within 12 months prior to the first study treatment infusion.
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Radiotherapy within 21 days prior to the first study treatment infusion.
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History of any other malignancy known to be active.
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Known human immunodeficiency virus infection.
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Patients with active infection requiring systemic anti-infective.
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Patients with positive test results for hepatitis B surface antigen or Hepatitis B core antigen.
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Patients with positive test results for hepatitis C virus (HCV) infection.
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Current active liver or biliary disease.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Winship Cancer Institute of Emory University | Atlanta | Georgia | United States | 30322 |
2 | Mount Sinai, The Tisch Cancer Instutute | New York | New York | United States | 10029 |
3 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
4 | Universitätsklinikum Heidelberg | Heidelberg | Germany | 69120 | |
5 | Universitätsklinikum Schleswig-Holstein | Kiel | Germany | 24105 | |
6 | Universitätsklinikum Mainz | Mainz | Germany | 55131 |
Sponsors and Collaborators
- Heidelberg Pharma AG
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- HDP-101-01