This is a first-in-human phase I, multicenter, open label, sequential-cohort, dose escalation study of ESG206. The purpose is to evaluate the clinical safety, tolerability, PK, and preliminary efficacy and to establish the MTD, if any, and RP2D(s) of ESG206 in adult subjects with B lymphoid malignancies.
This is a first-in-human phase I, multicenter, open label, sequential-cohort, dose escalation study of ESG206. The study will follow a modified 3+3 dose escalation scheme. Dose escalation will continue until identification of MTD or the predicted efficacy dose in the event that a MTD is not identified due to paucity of DLTs. Toxicity including dose-limiting toxicity (DLT) observed in Cycle 1 of the first 28 days will be used to determine escalation to the next dose level as described below. Five dose levels are planned. Dose choosing will be determined by the SMC and the sponsor based on the pharmacokinetics, tolerability and preliminary antitumor activities, as well as other available data. Subjects will be monitored for safety, tolerability, and efficacy throughout the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Administered via intravenous (IV) infusion
Percentage of Participants Experiencing Any Treatment Emergent Adverse Events
Treatment-emergent adverse events (TEAEs) were defined as: Any 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 Version 5.0.
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 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 (OR)
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
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ADA
Incidence of anti-drug antibodies
Time frame: Up to 20 months