A Phase 1 interventional study of ESG206 in B-cell Lymphoid Malignancies, sponsored by Shanghai Escugen Biotechnology Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Shanghai Escugen Biotechnology Co., Ltd · Phase 1, Interventional, and Treatment
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.
Shanghai Escugen Biotechnology Co., Ltd is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle
Drug: ESG206
ESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle
Drug: ESG206
ESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle
Drug: ESG206
ESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle
Drug: ESG206
Administered via intravenous (IV) infusion
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.
Time frame: First dose date up to last dose plus 30 days
Cmax
Maximum observed plasma concentration
Time frame: Up to 20 months
AUC0-inf
Area under the serum concentration time curve (AUC) from time 0 extrapolated to infinity
Time frame: Up to 20 months
Tmax
Time to maximum plasma concentration
Time frame: Up to 20 months
T1/2
Half-life
Time frame: Up to 20 months
Overall Response Rate (ORR)
Defined as complete response (CR) + partial response (PR)
Time frame: 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
Time frame: Up to 20 months
ADA
Incidence of anti-drug antibodies (ADA)
Time frame: Up to 20 months
Plan to share: No
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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Shanghai Escugen Biotechnology Co., Ltd