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This study is an open-label, dose-escalation and cohort expansion Phase I study, aiming to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of ESG406, and determine the MTD, RP2D and administration regimens of ESG406. The study includes the dose escalation study in Phase Ia and the cohort expansion study in Phase Ib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESG406 for injection | Experimental | The dosage is calculated based on the weight of the subjects and the corresponding dose group. Subjects will receive treatment until disease progression, or starts a new tumor treatment, or stops taking medication for other reasons. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESG406 | Drug | Administered via intravenous (IV) infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events | Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0. An AE that met one or more of the following outcomes was classified as serious: Fatal Life-threatening Disabling/incapacitating Results in hospitalization or prolongs a hospital stay A congenital abnormality Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above. | First dose date up to last dose plus 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective Response Rate(ORR) is defined as the rate an overall best response of either complete response (CR) or partial response (PR) . | Up to approximately 36 months. |
| Progression Free Survival |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoyan Xing, PhD | Contact | +86 21 5855 6098 | xingxiaoyan@escugen.com |
| Name | Affiliation | Role |
|---|---|---|
| Fuming Qiu, PhD | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing University Cancer Hospital | Recruiting | Chongqing | Chongqing Municipality | 400030 | China |
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Progression-free survival (PFS) is defined as the interval from the first dose start date to the date of disease progression defined as documented progressive disease (PD) or death from any cause, whichever occurs first.
| Up to approximately 36 months. |
| Cmax | Maximum observed plasma concentration | Up to approximately 36 months. |
| AUC0-inf | Area under the serum concentration time curve from time 0 extrapolated to infinity | Up to approximately 36 months. |
| T1/2 | Half-life | Up to approximately 36 months. |
| Anti-drug Antibodies | Incidence of anti-drug antibodies | Up to approximately 36 months. |
| The First Affiliated Hospital of Xi 'An Jiaotong University | Recruiting | Xi’an | Shanxi | 710061 | China |
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| The Second Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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