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

NCT04735575 | Terminated Phase 1 FDA Drug

• 1 other identifier: EMB06X101
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 10

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.

Conditions

Relapsed or Refractory Multiple Myeloma

Keywords

Phase I/II; Bispecific antibody; BCMA; CD3; EMB-06; Immuno-oncology; Dose escalation; Cohort expansion; Relapsed or Refractory Multiple Myeloma; Hematological malignancy

Outcome Measures

Primary Outcomes (6)

• Incidence and severity of adverse events

  Incidence and severity of AE.

  Screening up to follow-up (30 days after the last dose)

• Incidence of serious adverse events (SAE)

  Incidence of SAE

  Screening up to follow-up (30 days after the last dose)

• Incidence of dose interruptions.

  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)

• Dose intensity

  Actual amount of drug taken by patients divided by the planned amount.

  Screening up to follow-up (30 days after the last dose)

• The incidence of DLTs during treatment.

  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)

  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 Outcomes (10)

• Area under the serum concentration-time curve (AUC) of EMB-06.

  Through treatment until EOT visit, expected average 6 months

• Maximum serum concentration (Cmax) of EMB-06.

  Through treatment until EOT visit, expected average 6 months

• Trough concentration (Ctrough) of EMB-06.

  Through treatment until EOT visit, expected average 6 months

• Average concentration over a dosing interval (Css, avg) of EMB-06.

  Through treatment until EOT visit, expected average 6 months

• Terminal half-life (T1/2) of EMB-06.

  Through treatment until EOT visit, expected average 6 months

Study Arms (1)

EMB-06

EXPERIMENTAL

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

Interventions

EMB-06 BIOLOGICAL

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

EMB-06

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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 start of study treatment.
• Active or historically multiple myeloma related central nervous system involvement.

Sponsors & Collaborators

• Shanghai EpimAb Biotherapeutics Co., Ltd.: lead

Study Sites (10)

Sunshine Coast Haematology and Oncology Clinic (SCHOC)

Buderim, Queensland, 4556, Australia

Location

Epworth Healthcare

Richmond, Victoria, 3121, Australia

Location

One Clinical Research (OCR)

Nedlands, Western Australia, 6009, Australia

Location

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100035, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200020, China

Location

Peking University, Third Hospital

Beijing, China

Location

Guangdong Provincial People's Hospital

Guangzhou, China

Location

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

Location

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

Wuhan, China

Location

Henan Cancer Hospital

Zhengzhou, China

Location

MeSH Terms

Conditions

Recurrence; Multiple Myeloma; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Site

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation followed by Cohort Expansion Phase at the RP2D.

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 3, 2021
• Study Start: May 20, 2021
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); CN (7)