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Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
Trial Status: active
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.
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 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 Criteria
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.
Additional locations may be listed on ClinicalTrials.gov for NCT04879043.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute
Status: Active
Name Not Available
New York
New York
Icahn School of Medicine at Mount Sinai
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Temporarily closed to accrual
Name Not Available
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
