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NCT04879043PHASE1, PHASE2Recruiting

Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma

Heidelberg Pharma AG

Start Date

2/7/2022

Completion Date

9/1/2028

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.

Detailed 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

Age Range: 18 years to No maximum

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.

Interventions

DRUG

HDP-101

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Conditions

Multiple MyelomaPlasma Cell Disorder

Locations

Winship Cancer Institute of Emory University

Atlanta, Georgia 30322

United States

Norton Healthcare, Inc.

Louisville, Kentucky 40202

United States

Nebraska Cancer Institute

Omaha, Nebraska 68130

United States

Mount Sinai, The Tisch Cancer Instutute

New York, New York 10029

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

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

Berlin, 12203

Germany

Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III

Chemnitz, 09116

Germany

Universitätsklinikum Köln

Cologne, 50937

Germany

Asklepios Klinik Altona, Haematologie und internistische Onkologie

Hamburg, 22763

Germany

Universitätsklinikum Heidelberg

Heidelberg, 69120

Germany

Universitätsklinikum Schleswig-Holstein

Kiel, 24105

Germany

UKSH Campus Lübeck Klinik für Hämatologie und Onkologie

Lübeck, 23538

Germany

Universitätsklinikum Mainz

Mainz, 55131

Germany

Semmelweis University, Belgyogyaszati es Onkologiai Klinika

Budapest, 1083

Hungary

National Institute of Oncology, Department of Oncological Internal Medicine

Budapest, 1122

Hungary

Pécsi Tudományegyetem Klinikai Központ

Pécs, 7624

Hungary

Pratia Onkologia Katowice

Katowice, 40-568

Poland

Pratia Onkologia Kraków

Krakow, 40-519

Poland

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

Lodz, 93-513

Poland

Szpital Wojewodzki w Opolu

Opole, 45-061

Poland

AIDPORT Sp. zo.o.

Skórzewo, 60-185

Poland

MICS Centrum Medyczne Torun

Torun, 87-100

Poland

Arensia Clinics SRL

Bucharest,

Romania

Oncology Institute Prof. Dr. Ion Chiricuta I.O.C.N.

Cluj-Napoca,

Romania