RecruitingPhase 1Phase 2NCT04879043

Study to Assess Safety of HDP-101 in 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


Sponsor

Heidelberg Pharma AG

Enrollment

78 participants

Start Date

Feb 7, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests HDP-101, a new targeted antibody-drug that delivers a toxin directly to multiple myeloma cells, in patients whose myeloma has come back or stopped responding to multiple prior treatments. The drug targets a protein called BCMA found on myeloma cells. **You may be eligible if...** - You are 18 or older with confirmed active multiple myeloma - You have previously been treated with an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody - You have had a stem cell transplant or are considered ineligible for one - You still have measurable disease and your organ function meets the study requirements - Your expected survival is more than 12 weeks and your performance status is acceptable (ECOG 0–2) **You may NOT be eligible if...** - You have previously received any BCMA-targeting therapy (for the Phase 2a portion) - Your myeloma has spread to the brain - You have plasma cell leukemia - You have a history of congestive heart failure - You have received a stem cell transplant within the past 12 weeks - You have had radiation therapy in the past 21 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHDP-101

HDP-101 is available as lyophilized white powder for preparation of infusion.


Locations(16)

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Mount Sinai, The Tisch Cancer Instutute

New York, New York, United States

MD Anderson Cancer Center

Houston, Texas, United States

Charité - Campus Benjamin Franklin Med. Klinik m.S. Hämatologie, Onkologie

Berlin, Germany

Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III

Chemnitz, Germany

Universitätsklinikum Köln

Cologne, Germany

Asklepios Klinik Altona, Haematologie und internistische Onkologie

Hamburg, Germany

Universitätsklinikum Heidelberg

Heidelberg, Germany

Universitätsklinikum Schleswig-Holstein

Kiel, Germany

UKSH Campus Lübeck Klinik für Hämatologie und Onkologie

Lübeck, Germany

Universitätsklinikum Mainz

Mainz, Germany

Semmelweis University, Belgyogyaszati es Onkologiai Klinika

Budapest, Hungary

National Institute of Oncology, Department of Oncological Internal Medicine

Budapest, Hungary

Pratia Onkologia Katowice

Katowice, Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

Lodz, Poland

Szpital Wojewodzki w Opolu

Opole, Poland

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NCT04879043


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