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

NCT04879043 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: HDP-101-01
• Study Type: interventional
• Target: 78
• Locations: 4 countries
• Sites: 16

Brief 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.

Conditions

Multiple Myeloma; Plasma Cell Disorder

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (2)

• Assess the safety and tolerability of HDP-101

  Through study completion, an average of 1 year

• To assess the anticancer activity of HDP-101 in terms of time-to-event (TTE)

  Through study completion, an average of 1 year

Study Arms (1)

HDP-101

EXPERIMENTAL

Participants will receive HDP-101 intravenously in a 21 day cycle until disease progression, intolerable toxicity, Investigator's discretion or patient withdrawal. During the phase 1 tolerability of different dose levels will be evaluated. During the phase 2a dose expansion part the recommended phase 2 dose (RP2D) of HDP-101 will be administered.

Drug: HDP-101

Interventions

HDP-101 DRUG

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

HDP-101

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heidelberg Pharma AG: lead

Study Sites (16)

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Mount Sinai, The Tisch Cancer Instutute

New York, New York, 10029, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

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

Berlin, 12203, Germany

NOT YET RECRUITING

Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III

Chemnitz, 09116, Germany

RECRUITING

Universitätsklinikum Köln

Cologne, 50937, Germany

RECRUITING

Asklepios Klinik Altona, Haematologie und internistische Onkologie

Hamburg, 22763, Germany

RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein

Kiel, 24105, Germany

RECRUITING

UKSH Campus Lübeck Klinik für Hämatologie und Onkologie

Lübeck, 23538, Germany

RECRUITING

Universitätsklinikum Mainz

Mainz, 55131, Germany

WITHDRAWN

Semmelweis University, Belgyogyaszati es Onkologiai Klinika

Budapest, 1083, Hungary

RECRUITING

National Institute of Oncology, Department of Oncological Internal Medicine

Budapest, 1122, Hungary

RECRUITING

Pratia Onkologia Katowice

Katowice, 40-519, Poland

RECRUITING

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

Lodz, 93-513, Poland

NOT YET RECRUITING

Szpital Wojewodzki w Opolu

Opole, 45-061, Poland

NOT YET RECRUITING

Related 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

  BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

András Strassz, MD

CONTACT

+ 49 6203 1009 0; clinical@hdpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible patients will be enrolled and treated with intravenous HDP-101 every 3 weeks. In Phase 1 dose-escalation part from Cohort 6 additional treatment arms are introduced for dose-optimization purposes with dosing every 3 weeks, split dosing weekly or split dosing in the first cycle on Day1 and Day8. A Bayesian logistic regression model will be used to guide dose-escalation during Phase 1 and select the best dose for the Phase 2a of the study.

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: May 10, 2021
• Study Start: February 7, 2022
• Primary Completion: August 1, 2025
• Study Completion: May 1, 2026
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); DE (8); PL (3); HU (2)