Status:
RECRUITING
Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
Lead Sponsor:
Heidelberg Pharma AG
Conditions:
Multiple Myeloma
Plasma Cell Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04879043
Start Date
February 7 2022
End Date
May 1 2026
Last Update
July 24 2024
Active Locations (16)
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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
Charité - Campus Benjamin Franklin Med. Klinik m.S. Hämatologie, Onkologie
Berlin, Germany, 12203