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First in Human Study of EMB-07 in Locally Advanced/Metastatic Solid Tumors or Relapse/Refractory Lymphoma
For solid tumors and lymphoma, respectively: This study is to evaluate the safety and tolerability of EMB-07 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-07 will also be assessed.
Study details:
This is a phase I, multicenter, open label, dose escalation, first in human study, designed to assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose for EMB-07 in patient with locally advanced/metastatic solid tumors or relapse/refractory Lymphoma . 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: 2023-03-01
Primary completion: 2025-10-31
Study completion finish: 2026-03-31
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05607498
Intervention or treatment
DRUG: EMB07
Conditions
- • Advanced/Metastatic Solid Tumors
- • Relapse/Refractory Lymphoma
Find a site
Closest Location:
Peninsula and South Eastern Haematology and Oncology Group
Research sites nearby
Select from list below to view details:
Peninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia
One Clinical Research
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-07-Patients with solid tumor
| DRUG: EMB07
|
EXPERIMENTAL: EMB07-Patients with lymphoma
| DRUG: EMB07
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Incidence and severity of adverse events as assessed by CTCAE V5.0. | Incidence and severity of AE. | Screening up to 30 days after the last dose. |
Incidence of serious adverse events (SAE). | Incidence of SAE. | Screening up to 30 days after the last dose, or beyond 30 days if SAE is confirmed to be treatment related. |
Incidence of dose interruptions. | Incidence of dose interruptions of EMB-07 during treatment as a measure of tolerability. | Screening up to 30 days after the last dose. |
Dose intensity. | Actual amount of drug taken by patients divided by the planned amount. | Screening up to 30 days after the last dose. |
The incidence of DLTs during the first cycle of treatment. | The dose limiting toxicities 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). |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Overall response rate. | Overall response rate measured by RECIST V1.1, iWCLL-2018, Lugano 2014 | From the date of dosing untill the date of first documented progression or date of death from any casue, whichever case first, expected average 6 months. |
Area under the serum concentration-time curve (AUC) of EMB-07. | 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-07. | Blood samples for serum PK analysis will be obtained (Cmax). | Through treatment until EOT visit, expected average 6 months. |
Trough concentration (Ctrough) of EMB-07. | 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-07. | 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-07. | 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-07. | 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-07. | 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-07 as assessed by RECIST 1.1, iWCLL-2018, Lugano 2014 | 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. | Through treatment discontinuation: an average of 6 months |
Incidence and titer of anti-drug antibodies stimulated by EMB-07. | Antibodies to EMB-07 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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