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

August 31, 2023 updated by: Shanghai EpimAb Biotherapeutics Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Zhongqi Wu
  • Phone Number: +8613501633946 +8613501633946
  • Email: zqwu@epimab.com

Study Locations

  • Australia
    • Queensland
      • Buderim, Queensland, Australia, 4556
        • Recruiting
        • Sunshine Coast Haematology and Oncology Clinic (SCHOC)
        • Contact:
        • Principal Investigator:
          • Sorab Shavaksha, MBBS
    • Victoria
      • Melbourne, Victoria, Australia
        • Withdrawn
        • Cabrini Health
      • Richmond, Victoria, Australia, 3121
        • Recruiting
        • Epworth Healthcare
        • Contact:
        • Principal Investigator:
          • Miles Prince, FRACP
    • Western Australia
  • China
      • Beijing, China
        • Recruiting
        • Peking University, Third Hospital
        • Contact:
          • Hongmei Jing
      • Guangzhou, China
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
          • Peilong Lai
      • Hangzhou, China
        • Recruiting
        • The First Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:
          • Zhen Cai
      • Wuhan, China
        • Recruiting
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Chunrui Li
      • Zhengzhou, China
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • Qingsong Yin
    • Beijing
      • Beijing, Beijing, China, 100035
        • Recruiting
        • BeiJing JiShuiTan Hospital
        • Contact:
          • Li Bao
    • Shanghai
      • Shanghai, Shanghai, China, 200020
        • Recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
        • Contact:
          • Jianqing Mi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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, up to 10 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Screening up to follow-up (30 days after the last dose)
Incidence and severity of adverse events
Time Frame: Screening up to follow-up (30 days after the last dose)
Incidence and severity of AE.
Screening up to follow-up (30 days after the last dose)
Incidence of serious adverse events (SAE)
Time Frame: Screening up to follow-up (30 days after the last dose)
Incidence of SAE
Screening up to follow-up (30 days after the last dose)
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.
Screening up to follow-up (30 days after the last dose)
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.
First infusion to the end of Cycle 1 (each cycle is 28 days)
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Through treatment until EOT visit, expected average 6 months
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).
Through treatment until EOT visit, expected average 6 months
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).
Through treatment until EOT visit, expected average 6 months
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).
Through treatment until EOT visit, expected average 6 months
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).
Through treatment until EOT visit, expected average 6 months
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).
Through treatment until EOT visit, expected average 6 months
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).
Through treatment until EOT visit, expected average 6 months
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).
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
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).
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
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.
Up to End of Treatment Follow Up Period (30 days after the last dose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai EpimAb Biotherapeutics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2021

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

January 28, 2021

First Submitted That Met QC Criteria

February 1, 2021

First Posted (Actual)

February 3, 2021

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMB06X101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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