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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04879043
Other study ID # HDP-101-01
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date February 7, 2022
Est. completion date May 2025

Study information

Verified date July 2023
Source Heidelberg Pharma AG
Contact András Strassz, MD
Phone + 49 6203 1009 0
Email clinical@hdpharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 78
Est. completion date May 2025
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
Germany Charité - Campus Benjamin Franklin Med. Klinik m.S. Hämatologie, Onkologie Berlin
Germany Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III Chemnitz
Germany Asklepios Klinik Altona, Haematologie und internistische Onkologie Hamburg
Germany Universitätsklinikum Heidelberg Heidelberg
Germany Universitätsklinikum Schleswig-Holstein Kiel
Germany Universitätsklinikum Köln Köln
Germany UKSH Campus Lübeck Klinik für Hämatologie und Onkologie Lübeck
Germany Universitätsklinikum Mainz Mainz
Hungary National Institute of Oncology, Department of Oncological Internal Medicine Budapest
Hungary Semmelweis University, Belgyogyaszati es Onkologiai Klinika Budapest
Poland Pratia Onkologia Katowice Katowice
Poland Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Lódz
Poland Szpital Wojewodzki w Opolu Opole
United States Winship Cancer Institute of Emory University Atlanta Georgia
United States MD Anderson Cancer Center Houston Texas
United States Mount Sinai, The Tisch Cancer Instutute New York New York

Sponsors (1)

Lead Sponsor Collaborator
Heidelberg Pharma AG

Countries where clinical trial is conducted

United States,  Germany,  Hungary,  Poland, 

References & Publications (1)

Strassz A, Raab MS, Orlowski RZ, Kulke M, Schiedner G, Pahl A. A First in Human Study Planned to Evaluate HDP-101, an Anti-BCMA Amanitin Antibody-Drug Conjugate with a New Payload and a New Mode of Action, in Multiple Myeloma. Blood 2020; 136 (Supplement 1): 34. doi: https://doi.org/10.1182/blood-2020-142285

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients who experience dose-limiting toxicity (DLT) during the first cycle of treatment - Part 1 as defined in Clinical Study Protocol Up to Day 21 (from first dose)
Primary Objective response rate (ORR) Proportion of enrolled subjects who achieve a partial response (PR) or better, i.e. stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and PR, according to the IMWG criteria. Through study completion, an average of 1 year
Secondary Assess the safety and tolerability of HDP-101 Number of patients with serious and non-serious adverse events grouped by system organ class and preferred terms based on Common Terminology Criteria for Adverse Events (CTCAE v 5.0) classification. Through study completion, an average of 1 year
Secondary To assess the anticancer activity of HDP-101 in terms of time-to-event (TTE) Clinical efficacy of HDP-101 measured by Progression Free Survival (PFS) and Overall Survival (OS). Through study completion, an average of 1 year
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