A Ph1/2 Study of EMB-06 in Participants With Relapsed or Refractory Myeloma

Last updated: August 31, 2023
Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Bone Diseases

Cancer/tumors

Bone Neoplasm

Treatment

EMB-06

Clinical Study ID

NCT04735575
EMB06X101
  • Ages > 18
  • All Genders

Study Summary

The primary purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for EMB-06 and to characterize the safety and tolerability of EMB-06 at the RP2Ds. Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-06 will also be assessed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Able to understand and willing to sign the informed consent form (ICF)
  • Patients who have been diagnosed with multiple myeloma according to IMWG diagnosticcriteria 2014 and have relapsed or refractory multiple myeloma with at least onemeasurable lesion.
  • The patient must have received at least two lines (for patients in the US, at leastthree lines which should include anti-CD38 antibody) of prior antimyeloma therapies,and must have received treatment with proteasome inhibitors, immunomodulatory agents,and if accessible, an anti-CD38 targeting monoclonal antibody.
  • ECOG performance status 0 or 1 for phase I, and ≤2 for phase II.
  • Adequate organ function and reasonable laboratory test results to participate in thetrial.
  • Highly effective contraception

Exclusion

Exclusion Criteria:

  • Life expectancy is less than 3 months.
  • Patient participated in any other clinical study within 1 month prior to enrollment inthis clinical study.
  • Patients with ongoing AE.
  • Previously treated with any BCMA-targeted therapy.(Exception: in Phase 2 portion, upto 10 patients who have received prior anti-BCMA ADC or BCMA targeted CAR-T can beenrolled)
  • History of allogeneic stem cell transplantation.
  • Previously treated with the following anti-tumor therapy (prior to first dosing ofEMB-06)
  1. Treated with monoclonal antibody for multiple myeloma within 28 days
  2. Treated with proteasome inhibitors within 14 days
  3. Treated with immunomodulatory agents within 14 days
  4. Treated with cytotoxic therapy within 14 days
  5. Received investigational drug within 28 days or at least 5 half-lives, whicheveris shorter (if a, b, c, d not applicable)
  6. Received radiotherapy within 21 days. Except that the radiation portal covered ≤ 5% of the bone marrow reserve, the patient will be eligible to participate in thestudy regardless of the end date of radiation therapy
  7. Plasmapheresis within 7 days
  • Patient received autologous stem cell transplantation within 12 weeks prior to thestart of study treatment.
  • Active or historically multiple myeloma related central nervous system involvement.
  • Patients requiring high dose of systemic treatment with corticosteroids.
  • Patients with active infections, including COVID-19, hepatitis, etc..
  • History of severe allergic reactions
  • Patients with severe or uncontrolled cardiovascular disorder requiring treatment
  • Pre-existing other serious medical conditions

Study Design

Total Participants: 66
Treatment Group(s): 1
Primary Treatment: EMB-06
Phase: 1/2
Study Start date:
May 20, 2021
Estimated Completion Date:
March 01, 2025

Study Description

This is a Phase I/II, multi-center, open label, multiple-dose, first in human study, designed to assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for EMB-06 in patients with relapsed or refractory multiple myeloma. Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.

Connect with a study center

  • Sunshine Coast Haematology and Oncology Clinic (SCHOC)

    Buderim, Queensland 4556
    Australia

    Active - Recruiting

  • Cabrini Health

    Melbourne, Victoria
    Australia

    Site Not Available

  • Epworth Healthcare

    Richmond, Victoria 3121
    Australia

    Active - Recruiting

  • One Clinical Research (OCR)

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Beijing Jishuitan Hospital

    Beijing, Beijing 100035
    China

    Active - Recruiting

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai 200020
    China

    Active - Recruiting

  • Peking University, Third Hospital

    Beijing,
    China

    Active - Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou,
    China

    Active - Recruiting

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan,
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou,
    China

    Active - Recruiting

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