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

  • STATUS
    Recruiting
  • End date
    Mar 1, 2025
  • participants needed
    66
  • sponsor
    Shanghai EpimAb Biotherapeutics Co., Ltd.
Updated on 14 May 2022

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.

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.

Details
Condition Relapsed or Refractory Multiple Myeloma
Treatment EMB-06
Clinical Study IdentifierNCT04735575
SponsorShanghai EpimAb Biotherapeutics Co., Ltd.
Last Modified on14 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Willing and able to provide written informed consent
Patients who have been diagnosed with multiple myeloma according to IMWG diagnostic criteria 2014 and have relapsed or refractory multiple myeloma with at least one measurable lesion
The patient must have received at least two lines (for patients in the US, at least three 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 the trial
Highly effective contraception

Exclusion Criteria

Life expectancy is less than 3 months
Patient participated in any other clinical study within 1 month prior to enrollment in this clinical study
Patients with ongoing AE
Previously treated with any BCMA-targeted therapy.(Exception: in Phase 2 portion, partial patients who have received prior anti-BCMA ADC or BCMA targeted CAR-T can be enrolled)
History of allogeneic stem cell transplantation
Previously treated with the following anti-tumor therapy (prior to first dosing of EMB-06)
Treated with monoclonal antibody for multiple myeloma within 28 days
Treated with proteasome inhibitors within 14 days
Treated with immunomodulatory agents within 14 days
Treated with cytotoxic therapy within 14 days
Received investigational drug within 28 days or at least 5 half-lives, whichever is shorter (if a, b, c, d not applicable)
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 the study regardless of the end date of radiation therapy
Plasmapheresis within 7 days
Patient received autologous stem cell transplantation within 12 weeks prior to the
Active or historically multiple myeloma related central nervous system involvement
start of study treatment
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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