Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
18 Years and older, Male and Female
HDP-101-01 (primary)
NCI-2021-04304
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.
Objectives
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.
Eligibility
- 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.
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