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A Ph1/2 Study of EMB-06 in Participants With Relapsed or Refractory 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 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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
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
| BIOLOGICAL: EMB-06
|
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) |
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