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Recruiting NCT07529782

Study to Assess Safety and Efficacy of HDP-101 in Chinese Patients With Relapsed or Refractory Multiple Myeloma

Phase I Interventional Multiple Myeloma and Other Plasma Cell Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HDP-101.
Who it may be relevant to
Registry conditions: Multiple Myeloma and Other Plasma Cell Neoplasms. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Chinese Patients With Plasma Cell Disorders Including Multiple Myeloma

Overview

This study is a 2-part study with a dose-escalation part and a dose-expansion part. The aim of the dose-escalation part is to determine the maximum tolerated dose (MTD) and/or establish the recommended Phase 2 dose (RP2D) in the Chinese population, in order to select the treatment dose for the dose-expansion part. The dose-escalation part will be followed by the dose-expansion part once the MTD(s) and/or RP2D of HDP-101 monotherapy in the Chinese population have been determined. The dose-expansion part of the study is intended to collect preliminary evidence of antitumor activity and to confirm the safety of the HDP-101 as monotherapy in Chinese patients with r/r MM.

Interventions

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

Primary outcome measures

  • Number of patients who experience a dose-limiting toxicity (DLT) during the first cycle of treatment. [Time frame: Up to Day 21 (from first dose)]
Secondary outcome measures (7)
  • Number of patients with serious and non-serious adverse events [Time frame: Through study completion, an average of 1 year]
  • Objective response rate (ORR) [Time frame: Through study completion, an average of 1 year]
  • Minimal residual disease (MRD) negativity rate [Time frame: Through study completion, an average of 1 year]
  • Progression-free survival (PFS) [Time frame: Through study completion, an average of 1 year]
  • Duration of response (DOR) [Time frame: Through study completion, an average of 1 year]
  • Time to objective response (TOR) [Time frame: Through study completion, an average of 1 year]
  • Overall survival (OS) [Time frame: Through study completion, an average of 1 year]

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 (Dose-escalation part only: patients with non-secretory or oligo-secretory myeloma (NSMM) not meeting the measurability criteria are eligible).
  • Adequate organ system function as defined in protocol.

Exclusion criteria

  • 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 therapy.
  • Patients with positive hepatitis B virus (HBV) infection or positive hepatitis C virus (HCV) infection.
  • Current active liver or biliary disease.
  • Pregnancy or breast feeding.
  • Pneumonia or symptomatic pneumonitis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 5 centers
  • Beijing Chao-Yang Hospital, Capital Medical University — Beijing
  • The First Affiliated Hospital of Soochow University — Suzhou
  • Qilu Hospital of Shandong University — Jinan
  • Institute of Hematology & Blood Diseases Hospital,Chinese Academy of Medical Sciences — Tianjin
  • The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT07529782 · HDP-101-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗