NCT05822843

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

August 2, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2025

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

1.5 years

First QC Date

April 10, 2023

Last Update Submit

September 8, 2025

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 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.

    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 Rate (ORR)

    Up to 20 months

  • +2 more secondary outcomes

Study Arms (4)

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 1 every two weeks in a 28-day cycle

Drug: ESG206

ESG206 dose level 3

EXPERIMENTAL

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

Drug: ESG206

ESG206 dose level 4

EXPERIMENTAL

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

Drug: ESG206

Interventions

ESG206DRUG

Administered via intravenous (IV) infusion

ESG206 dose level 1ESG206 dose level 2ESG206 dose level 3ESG206 dose level 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

Location

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

April 10, 2023

First Posted

April 21, 2023

Study Start

August 2, 2023

Primary Completion

January 22, 2025

Study Completion

January 22, 2025

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)