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

A Phase 1/2a, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Patients With Plasma Cell Disorders Including Multiple Myeloma

This study is testing a new treatment called HDP-101 to see if it is safe and effective for people with relapsed or refractory multiple myeloma.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Heidelberg Pharma AG (Industry-sponsored)
• Locations: 16 sites (Atlanta, Georgia and 15 other locations)
• Trial ID: NCT04879043 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory multiple myeloma who have undergone prior treatments and meet specific eligibility criteria.

Not a fit: Patients who have previously received BCMA-targeting therapies will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with relapsed refractory multiple myeloma.

How similar studies have performed: Other studies targeting BCMA in multiple myeloma have shown promising results, indicating potential for success with this approach.

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.

Where this trial is running

Atlanta, Georgia and 15 other locations

• Winship Cancer Institute of Emory University — Atlanta, Georgia, 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)
• Charité - Campus Benjamin Franklin Med. Klinik m.S. Hämatologie, Onkologie — Berlin, Germany (Not_yet_recruiting)
• Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III — Chemnitz, Germany (Recruiting)
• Universitätsklinikum Köln — Cologne, Germany (Recruiting)
• Asklepios Klinik Altona, Haematologie und internistische Onkologie — Hamburg, Germany (Recruiting)
• Universitätsklinikum Heidelberg — Heidelberg, Germany (Recruiting)
• Universitätsklinikum Schleswig-Holstein — Kiel, Germany (Recruiting)
• UKSH Campus Lübeck Klinik für Hämatologie und Onkologie — Lübeck, Germany (Recruiting)
• Universitätsklinikum Mainz — Mainz, Germany (Withdrawn)
• Semmelweis University, Belgyogyaszati es Onkologiai Klinika — Budapest, Hungary (Recruiting)
• National Institute of Oncology, Department of Oncological Internal Medicine — Budapest, Hungary (Recruiting)
• Pratia Onkologia Katowice — Katowice, Poland (Recruiting)
• Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi — Lodz, Poland (Not_yet_recruiting)
• Szpital Wojewodzki w Opolu — Opole, Poland (Not_yet_recruiting)

Study contacts

• Study coordinator: András Strassz, MD

Conditions Multiple Myeloma; Plasma Cell Disorder