NCT05263739

A First-in-Human Phase I Study of ESG206 in Subjects With B-cell Lymphoid Malignancies

A First-in-Human Phase I, Open Label, Multiple Dose, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of Anti-BAFFR mAb, ESG206 in Subjects With B-cell Lymphoid Malignancies

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Shanghai Escugen Biotechnology Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• B-cell Lymphoid Malignancies

Interventions

Type	Name	Description
DRUG	ESG206	Administered via intravenous (IV) infusion

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2022-03-03
• Last updated: 2025-09-12