Back to resultsStudy to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
Primary Purpose
Multiple Myeloma, Plasma Cell Disorder
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
HDP-101
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- Male or female aged ≥18 years.
- Life expectancy >12 weeks.
- Eastern Cooperative Oncology Group Performance Status (PS) of 0 to 1.
- 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.
Sites / Locations
- Winship Cancer Institute of Emory UniversityRecruiting
- Mount Sinai, The Tisch Cancer InstututeRecruiting
- MD Anderson Cancer CenterRecruiting
- Charité - Campus Benjamin Franklin Med. Klinik m.S. Hämatologie, Onkologie
- Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III
- Asklepios Klinik Altona, Haematologie und internistische Onkologie
- Universitätsklinikum HeidelbergRecruiting
- Universitätsklinikum Schleswig-HolsteinRecruiting
- Universitätsklinikum Köln
- UKSH Campus Lübeck Klinik für Hämatologie und Onkologie
- Universitätsklinikum MainzRecruiting
- Semmelweis University, Belgyogyaszati es Onkologiai Klinika
- National Institute of Oncology, Department of Oncological Internal MedicineRecruiting
- Pratia Onkologia KatowiceRecruiting
- Szpital Wojewodzki w Opolu
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HDP-101
Arm Description
Participants will receive HDP-101 intravenously at one dose every 3 weeks (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.
Outcomes
Primary Outcome Measures
Number of patients who experience dose-limiting toxicity (DLT) during the first cycle of treatment - Part 1 as defined in Clinical Study Protocol
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.
Secondary Outcome Measures
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04879043
Brief Title
Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heidelberg Pharma AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Plasma Cell Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Eligible patients will be enrolled and treated with intravenous HDP-101 every 3 weeks.
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HDP-101
Arm Type
Experimental
Arm Description
Participants will receive HDP-101 intravenously at one dose every 3 weeks (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.
Intervention Type
Drug
Intervention Name(s)
HDP-101
Intervention Description
HDP-101 is available as lyophilized white powder for preparation of infusion.
Primary Outcome Measure Information:
Title
Number of patients who experience dose-limiting toxicity (DLT) during the first cycle of treatment - Part 1 as defined in Clinical Study Protocol
Time Frame
Up to Day 21 (from first dose)
Title
Objective response rate (ORR)
Description
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.
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Assess the safety and tolerability of HDP-101
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
To assess the anticancer activity of HDP-101 in terms of time-to-event (TTE)
Description
Clinical efficacy of HDP-101 measured by Progression Free Survival (PFS) and Overall Survival (OS).
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
András Strassz, MD
Phone
+ 49 6203 1009 0
Email
clinical@hdpharma.com
Facility Information:
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
Mount Sinai, The Tisch Cancer Instutute
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Charité - Campus Benjamin Franklin Med. Klinik m.S. Hämatologie, Onkologie
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Asklepios Klinik Altona, Haematologie und internistische Onkologie
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
UKSH Campus Lübeck Klinik für Hämatologie und Onkologie
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinikum Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Semmelweis University, Belgyogyaszati es Onkologiai Klinika
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
National Institute of Oncology, Department of Oncological Internal Medicine
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Pratia Onkologia Katowice
City
Katowice
ZIP/Postal Code
40-519
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpital Wojewodzki w Opolu
City
Opole
ZIP/Postal Code
45-061
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
City
Łódź
ZIP/Postal Code
93-513
Country
Poland
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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
Results Reference
background
Links:
URL
https://ashpublications.org/blood/article/136/Supplement%201/34/472856/A-First-in-Human-Study-Planned-to-Evaluate-Hdp-101
Description
Oral presentation - ASH Congress 2020
Learn more about this trial
Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
We'll reach out to this number within 24 hrs