Beijing Cancer Hospital
Beijing, China
NCT Number: NCT05822843
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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Notify Me18 year and older
All sexes
Interventional
Phase 1
Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered via intravenous (IV) infusion
Time frame: First dose date up to last dose plus 30 days
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: Up to 20 months
Maximum observed plasma concentration
Time frame: Up to 20 months
Area under the serum concentration time curve (AUC) from time 0 extrapolated to infinity
Time frame: Up to 20 months
Time to maximum plasma concentration
Time frame: Up to 20 months
Half-life
Time frame: Up to 20 months
Defined as complete response (CR) + partial response (PR)
Time frame: Up to 20 months
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
Incidence of anti-drug antibodies (ADA)
Shanghai Escugen Biotechnology Co., Ltd
Industry
A Phase I, Open Label, Multiple Dose, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of Anti-BAFFR mAb(Monoclonal Antibody), ESG206 in Subjects With B-cell Lymphoid Malignancies
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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