Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
Sponsor: Heidelberg Pharma AG
ClinicalTrials ID:NCT04879043
The study evaluates HDP-101's safety, tolerability, PK, and antitumor activity in relapsed/refractory MM patients. It includes dose escalation and expansion phases using a Bayesian model. Eligible participants are adults with confirmed MM, prior treatments, and adequate organ function. HDP-101 is administered as an infusion.
Patient Parameters
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Program Overview
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.
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.
Eligibility Criteria
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Winship Cancer Institute of Emory University | 30322 | Atlanta | Georgia |
| Mount Sinai, The Tisch Cancer Instutute | 10029 | New York | New York |
| MD Anderson Cancer Center | 77030 | Houston | Texas |
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