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

NCT05263739 | Withdrawn Phase 1 DMC

• 1 other identifier: ESG206-101
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

B-cell Lymphoid Malignancies

Outcome Measures

Primary Outcomes (1)

• 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.

  First dose date up to last dose plus 30 days

Secondary Outcomes (7)

• Cmax

  Up to 20 months

• AUC0-inf

  Up to 20 months

• Tmax

  Up to 20 months

• T1/2

  Up to 20 months

• Overall Response (OR)

  Up to 20 months

Study Arms (5)

ESG206 dose level 1

EXPERIMENTAL

ESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle.

Drug: ESG206

ESG206 dose level 2

EXPERIMENTAL

ESG206 will be administered intravenously at dose level 2 every two weeks in a 28-day cycle.

Drug: ESG206

ESG206 dose level 3

EXPERIMENTAL

ESG206 will be administered intravenously at dose level 3 every two weeks in a 28-day cycle.

Drug: ESG206

ESG206 dose level 4

EXPERIMENTAL

ESG206 will be administered intravenously at dose level 4 every two weeks in a 28-day cycle.

Drug: ESG206

ESG206 dose level 5

EXPERIMENTAL

ESG206 will be administered intravenously at dose level 5 every two weeks in a 28-day cycle.

Drug: ESG206

Interventions

ESG206 DRUG

Administered via intravenous (IV) infusion

ESG206 dose level 1; ESG206 dose level 2; ESG206 dose level 3; ESG206 dose level 4; ESG206 dose level 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent for the trial.
• Male or female and at least 18 years of age.
• Subjects must have a histologically confirmed (or documented), incurable B-cell hematologic malignancy that had progressed despite standard of care therapy and for which there was no alternative therapy of proven benefit or no effective standard therapy is available or tolerable.
• Measurable or evaluable Disease.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Subject must have adequate organ function.

You may not qualify if:

• Has had prior chemotherapy, targeted therapy, immunotherapy or any other agents used as systemic treatment for cancer, within 14 days before first dosing.
• Had major surgery within 4 weeks before first dosing.
• Had undergone an autologous stem cell transplant within 100 days before first dosing.
• Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, or renal disease).
• Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the investigational product or excipients.
• Pregnant or breastfeeding women.
• Unwillingness or inability to follow the procedures outlined in the protocol.

Sponsors & Collaborators

• Shanghai Escugen Biotechnology Co., Ltd: lead
• Escugen (Australia) Biotechnology Pty Ltd: collaborator

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 3, 2022
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share