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

PHASE1PHASE2RECRUITING

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.

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Study details:

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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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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)

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.

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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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-05-20

Primary completion: 2023-12-01

Study completion finish: 2025-03-01

Study type

TREATMENT

Phase

PHASE1

PHASE2

Trial ID

NCT04735575

Intervention or treatment

BIOLOGICAL: EMB-06

Conditions

• Relapsed or Refractory Multiple Myeloma

$Image related to Relapsed or Refractory Multiple Myeloma$

Condition: Relapsed or Refractory Multiple Myeloma
BIOLOGICAL: EMB-06
Richmond, Victoria, Australia and more
Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Epworth Healthcare

Research sites nearby

Select from list below to view details:

Epworth Healthcare
Richmond, Victoria, Australia
Sunshine Coast Haematology and Oncology Clinic (SCHOC)
Buderim, Queensland, Australia
Cabrini Health
Melbourne, Victoria, Australia
One Clinical Research (OCR)
Nedlands, Western Australia, Australia

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?

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

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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 outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Area under the serum concentration-time curve (AUC) of EMB-06.	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.	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.	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.	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.	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.	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.	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.	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	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.	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)

Frequently Asked Questions

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References

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