Assessing the safety of HDP-101 for patients with relapsed refractory multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics, and therapeutic potential of HDP-101 in patients with plasma cell disorders, particularly relapsed or refractory multiple myeloma. It consists of two parts: a dose escalation phase to determine the maximum tolerated dose (MTD) and a dose expansion phase to gather preliminary evidence of antitumor activity and confirm safety. The study employs an adaptive Bayesian logistic regression model for dose escalation, ensuring overdose control while assessing clinical activity. Participants must have a confirmed diagnosis of active multiple myeloma and have undergone prior treatments.

Why it matters

Who can join: the full rules

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.

Where it's running

• Winship Cancer Institute of Emory University
  Atlanta, Georgia, United States Recruiting
• Nebraska Cancer Institute
  Omaha, Nebraska, United States Recruiting
• Mount Sinai, The Tisch Cancer Instutute
  New York, New York, United States Recruiting
• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• Semmelweis University, Belgyogyaszati es Onkologiai Klinika
  Budapest, Hungary Recruiting
• Pratia Onkologia Katowice
  Katowice, Poland Recruiting

Study contacts

• Study coordinator: Lei Wang, MD
• Email: clinical@hdpharma.com
• Phone: + 49 6203 1009 0

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.