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This is a phase I, multicenter, open label, sequential-cohort, dose escalation study of ESG206. The purpose is to evaluate the clinical safety, tolerability, PK (pharmacokinetics), and preliminary efficacy and to establish the MTD (maximum tolerated dose), if any, and RP2D (recommended phaseII dose) of ESG206 in adult subjects with B lymphoid malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESG206 dose level 1 | Experimental | ESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle |
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| ESG206 dose level 2 | Experimental | ESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle |
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| ESG206 dose level 3 | Experimental | ESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle |
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| ESG206 dose level 4 | Experimental | ESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESG206 | Drug | Administered via intravenous (IV) infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Any Treatment Emergent Adverse Events | Treatment-emergent adverse events (TEAEs) were defined as: Any adverse event (AE) that happens after treatment initiation, or AE that was present at time of treatment initiation but worsened after treatment initiation, or AE that was present and resolved prior to treatment and reappeared after treatment initiation 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. | First dose date up to last dose plus 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum observed plasma concentration | Up to 20 months |
| AUC0-inf | Area under the serum concentration time curve (AUC) from time 0 extrapolated to infinity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | China |
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| Up to 20 months |
| Tmax | Time to maximum plasma concentration | Up to 20 months |
| T1/2 | Half-life | Up to 20 months |
| Overall Response Rate (ORR) | Defined as complete response (CR) + partial response (PR) | Up to 20 months |
| Progression-free Survival (PFS) | Defined as the interval from the start of study therapy to the earlier of the first documentation of disease progression or death from any cause | Up to 20 months |
| ADA | Incidence of anti-drug antibodies (ADA) | Up to 20 months |