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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04879043
• Other study ID #: HDP-101-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Paraproteinemias
• Plasma Cell Disorder

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

External Links

•   Oral presentation - ASH Congress 2020