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

• ClinicalTrials.gov Identifier: NCT04735575
• Recruitment Status: Recruiting
• First Posted: February 3, 2021
• Last Update Posted: September 1, 2023
• Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.
• Information provided by (Responsible Party): Shanghai EpimAb Biotherapeutics Co., Ltd.

Tracking Information

• First Submitted Date: January 28, 2021
• First Posted Date: February 3, 2021
• Last Update Posted Date: September 1, 2023
• Actual Study Start Date: May 20, 2021
• Estimated Primary Completion Date: December 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 1, 2021)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 1, 2021)

• 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).
• 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).
• 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).
• 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).
• 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).
• 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).
• 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).
• 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).
• 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).
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Ph1/2 Study of EMB-06 in Participants With Relapsed or Refractory Myeloma
• 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
• 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.
• 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
• Study Phase: Phase 1; Phase 2

Study Design

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

• Condition: Relapsed or Refractory Multiple Myeloma

Intervention

Biological: EMB-06

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

Study Arms

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.

Intervention: Biological: EMB-06

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 1, 2021): 66
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 1, 2025
• Estimated Primary Completion Date: December 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Shuqi Zeng; +8618621781427; shqzeng@epimab.com

Contact: Zhongqi Wu; +8613501633946 ext +8613501633946; zqwu@epimab.com

• Listed Location Countries: Australia, China

Administrative Information

• NCT Number: NCT04735575
• Other Study ID Numbers: EMB06X101
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Shanghai EpimAb Biotherapeutics Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Shanghai EpimAb Biotherapeutics Co., Ltd.
• Verification Date: August 2023