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This study is to evaluate the safety and tolerability of EMB-09 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-09 will also be assessed.
This is a phase I, 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 for EMB-09 in patient with advanced or metastatic solid tumors. Pharmacokinetics,pharmacodynamics, immunogenicity and response will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: EMB-09 | Experimental | Participants enrolled at different time will receive EMB-09 once a week (IV) at different ascending dose levels. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMB-09 | Biological | EMB-09 is a FIT-Ig® bispecific antibody against PD-L1 and OX40. |
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| Measure | Description | 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-09 during treatment as a measure of tolerability. | Screening up to 30 days after the las 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | Measured by RECIST 1.1. | From the date of dosing until the date of first documented progression or date of death from any cause, whichever case first, expected average 6 months. |
| Area under the serum concentration-time curve (AUC) of EMB-09 |
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Inclusion Criteria:
Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
Phase I subjects:
Patients must provide archival tumor, or a fresh tumor biopsy will be required if archival tumor sample is not available. Archival tumor sample must be taken <2 years prior to screening, otherwise a fresh tumor biopsy at screening is required.
ECOG performance status 0 or 1; life expectancy > 3 months.
Adequate organ function to participate in the trial.
Recovery from adverse events (AEs) related to prior anticancer therapy.
Highly effective contraception
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuqi Zeng, MD. | Contact | +86-21-61043299 | shqzeng@epimab.com | |
| Di Hu | Contact | +86-21-61043299 | xyang@epimab.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peninsula and South Eastern Haematology & Oncology Group | Recruiting | Frankston | Australia |
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Single Group Assignment Dose escalation followed by Cohort Expansion Phase at the RP2D.
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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-09 | Blood samples for serum PK analysis will be obtained (Cmax) | Through treatment until EOT visit, expected average 6 months |
| Trough concentration (Ctrough) of EMB-09 | 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-09. | 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-09 | 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-09 | 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-09 | 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-09 as assessed by RECIST 1 | Preliminary anti-tumor activity of EMB-09 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-09 | Antibodies to EMB-09 will be assessed to evaluate potential immunogenicity. | Up to End of Treatment Follow Up Period (30 days after the last dose |
| GenesisCareNorthShore | Recruiting | Leonards Hill | Australia |
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| Blacktown Hospital | Recruiting | Sydney | Australia |
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| FUSCC | Recruiting | Shanghai | China |
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