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

Sponsor
Heidelberg Pharma AG (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04879043
Collaborator
(none)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
78 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 7, 2022
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: HDP-101

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.

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

Outcome Measures

Primary Outcome Measures

  1. 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)]

  2. Objective response rate (ORR) [Through study completion, an average of 1 year]

    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

  1. Assess the safety and tolerability of HDP-101 [Through study completion, an average of 1 year]

    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.

  2. To assess the anticancer activity of HDP-101 in terms of time-to-event (TTE) [Through study completion, an average of 1 year]

    Clinical efficacy of HDP-101 measured by Progression Free Survival (PFS) and Overall Survival (OS).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Winship Cancer Institute of Emory University Atlanta Georgia United States 30322
2 Mount Sinai, The Tisch Cancer Instutute New York New York United States 10029
3 MD Anderson Cancer Center Houston Texas United States 77030
4 Universitätsklinikum Heidelberg Heidelberg Germany 69120
5 Universitätsklinikum Schleswig-Holstein Kiel Germany 24105
6 Universitätsklinikum Mainz Mainz Germany 55131

Sponsors and Collaborators

  • Heidelberg Pharma AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Heidelberg Pharma AG
ClinicalTrials.gov Identifier:
NCT04879043
Other Study ID Numbers:
  • HDP-101-01
First Posted:
May 10, 2021
Last Update Posted:
Mar 11, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 11, 2022