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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMB-07-Patients with solid tumor | Experimental | Patients with solid tumor will receive intravenous infusions of EMB-07 weekly (QW). Dose escalation will continue until the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is reached or all planned doses are administered. |
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| EMB07-Patients with lymphoma | Experimental | Patients with lymphoma will receive intravenous infusions of EMB-07 weekly (QW). Dose escalation will continue until the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is reached or all planned doses are administered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMB07 | Drug | EMB07 is a MAT-Fab bispecific antibody against CD3 and RORI |
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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-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). |
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sai Lou | Contact | +8613758235260 | slou@epimab.com | |
| Junqiang He | Contact | +8618302157016 | jqhe@epimab.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peninsula and South Eastern Haematology and Oncology Group | Recruiting | Frankston | Victoria | Australia |
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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-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) |
| One Clinical Research | Recruiting | Nedlands | Western Australia | Australia |
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| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | China |
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| Affiliated Hospital of Hebei University | Recruiting | Baoding | China |
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| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | China |
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| The First Affiliated Hospital of Bengbu Medical College | Recruiting | Bengbu | China |
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| Zhujiang Hospital of Southern Medical University | Recruiting | Guangzhou | China |
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| The Affiliated Tumour Hospital of Harbin Medical University | Recruiting | Harbin | China |
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| Shandong Cancer Hospital | Recruiting | Shandong | China |
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| Tianjin Medical University Cancer Institue & Hospital | Recruiting | Tianjin | China |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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