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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04735575
Recruitment Status : Recruiting
First Posted : February 3, 2021
Last Update Posted : May 6, 2022
Sponsor:
Information provided by (Responsible Party):
Shanghai EpimAb Biotherapeutics Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Multiple Myeloma Biological: EMB-06 Phase 1 Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Dose escalation followed by Cohort Expansion Phase at the RP2D.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A First-in-human, Phase I/II, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of EMB-06 in Patients With Relapsed or Refractory Multiple Myeloma
Actual Study Start Date : May 20, 2021
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : March 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: EMB-06

In Phase I part: participants enrolled at different time will receive EMB-06 by IV infusion at different ascending dose levels.

In Phase II part: participants will receive EMB-06 by IV infusion at previously defined RP2D.

Biological: EMB-06
EMB-06 is a FIT-Ig® bispecific antibody against BCMA and CD3.




Primary Outcome Measures :
  1. Incidence and severity of adverse events [ Time Frame: Screening up to follow-up (30 days after the last dose) ]
    Incidence and severity of AE.

  2. Incidence of serious adverse events (SAE) [ Time Frame: Screening up to follow-up (30 days after the last dose) ]
    Incidence of SAE

  3. Incidence of dose interruptions. [ Time Frame: Screening up to follow-up (30 days after the last dose) ]
    Incidence of dose interruptions of EMB-06 during treatment as a measure of tolerability.

  4. Dose intensity [ Time Frame: Screening up to follow-up (30 days after the last dose) ]
    Actual amount of drug taken by patients divided by the planned amount.

  5. The incidence of DLTs during treatment. [ Time Frame: First infusion to the end of Cycle 1 (each cycle is 28 days) ]
    The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and are specifically defined in study protocol.

  6. Overall Response Rate (ORR) [ Time Frame: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months ]
    Measured by IMWG criteria, only applicable in Phase II part


Secondary Outcome Measures :
  1. Area under the serum concentration-time curve (AUC) of EMB-06. [ Time Frame: Through treatment until EOT visit, expected average 6 months ]
    Blood samples for serum PK analysis will be obtained (AUC).

  2. Maximum serum concentration (Cmax) of EMB-06. [ Time Frame: Through treatment until EOT visit, expected average 6 months ]
    Blood samples for serum PK analysis will be obtained (Cmax).

  3. Trough concentration (Ctrough) of EMB-06. [ Time Frame: Through treatment until EOT visit, expected average 6 months ]
    Blood samples for serum PK analysis will be obtained (Ctrough).

  4. Average concentration over a dosing interval (Css, avg) of EMB-06. [ Time Frame: Through treatment until EOT visit, expected average 6 months ]
    Blood samples for serum PK analysis will be obtained (Css, avg).

  5. Terminal half-life (T1/2) of EMB-06. [ Time Frame: Through treatment until EOT visit, expected average 6 months ]
    Blood samples for serum PK analysis will be obtained (T1/2).

  6. Systemic clearance (CL) of EMB-06. [ Time Frame: Through treatment until EOT visit, expected average 6 months ]
    Blood samples for serum PK analysis will be obtained (CL).

  7. Steady state volume of distribution (Vss) of EMB-06. [ Time Frame: Through treatment until EOT visit, expected average 6 months ]
    Blood samples for serum PK analysis will be obtained (Vss).

  8. Progression free survival (PFS) of EMB-06 as assessed by IMWG criteria. [ Time Frame: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months ]
    Preliminary anti-multiple myeloma activity of EMB-06 will be obtained (PFS).

  9. Duration of response of EMB-06 as assessed by IMWG criteria [ Time Frame: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months ]
    Preliminary anti-multiple myeloma activity of EMB-06 will be obtained (DOR).

  10. Incidence and titer of anti-drug antibodies stimulated by EMB-06. [ Time Frame: Up to End of Treatment Follow Up Period (30 days after the last dose) ]
    Antibodies to EMB-06 will be assessed to evaluate potential immunogenicity.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

    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, whichever is 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 the study regardless of the end date of radiation therapy
    7. Plasmapheresis within 7 days
  • Patient received autologous stem cell transplantation within 12 weeks prior to the start 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04735575


Contacts
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Contact: Shuqi Zeng +8618621781427 shqzeng@epimab.com
Contact: Zhongqi Wu +8613501633946 ext +8613501633946 zqwu@epimab.com

Locations
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Australia, Queensland
Sunshine Coast Haematology and Oncology Clinic (SCHOC) Recruiting
Buderim, Queensland, Australia, 4556
Contact: Susan Poechhacker, RN    +617 5456 5515    spoechha@usc.edu.au   
Principal Investigator: Sorab Shavaksha, MBBS         
Australia, Victoria
Cabrini Health Recruiting
Melbourne, Victoria, Australia
Contact: Khaira Simer       SKhaira@cabrini.com.au   
Principal Investigator: Kenealy Melita         
Epworth Healthcare Recruiting
Richmond, Victoria, Australia, 3121
Contact: Elena Bayly-McCredie, RN    +613 9483 6041    Elena.Bayly-McCredie@epworth.org.au   
Principal Investigator: Miles Prince, FRACP         
Australia, Western Australia
One Clinical Research (OCR) Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Samantha Blades, RN    +618 6279 9466    samantha.blades@oneclinicalresearch.com.au   
Contact: Scott McGregor, BPharm    +618 6279 9466    scott.mcgregor@oneclinicalresearch.com.au   
Principal Investigator: Peter Tan, FRACP         
China, Beijing
Beijing Jishuitan Hospital Recruiting
Beijing, Beijing, China, 100035
Contact: Li Bao         
China, Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200020
Contact: Jianqing Mi         
Sponsors and Collaborators
Shanghai EpimAb Biotherapeutics Co., Ltd.
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Responsible Party: Shanghai EpimAb Biotherapeutics Co., Ltd.
ClinicalTrials.gov Identifier: NCT04735575    
Other Study ID Numbers: EMB06X101
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: May 6, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai EpimAb Biotherapeutics Co., Ltd.:
Phase I/II
Bispecific antibody
BCMA
CD3
EMB-06
Immuno-oncology
Dose escalation
Cohort expansion
Relapsed or Refractory Multiple Myeloma
Hematological malignancy
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases