A Phase 1 Study of ESG206 in Adult Subjects With B-cell Lymphoid Malignancies

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

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.

Study Overview

• Status: Recruiting
• Conditions: B-cell Lymphoid Malignancies
• Intervention / Treatment: Drug: ESG206

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xiaoyan Xing, PhD; Phone Number: +86 21 5855 6098; Email: xingxiaoyan@escugen.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Cancer hospital
    • Contact: Yuqing Song, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESG206 dose level 1; ESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle	Drug: ESG206; Administered via intravenous (IV) infusion
Experimental: ESG206 dose level 2; ESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle	Drug: ESG206; Administered via intravenous (IV) infusion
Experimental: ESG206 dose level 3; ESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle	Drug: ESG206; Administered via intravenous (IV) infusion
Experimental: ESG206 dose level 4; ESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle	Drug: ESG206; Administered via intravenous (IV) infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum observed plasma concentration	Up to 20 months
Tmax	Time to maximum plasma concentration	Up to 20 months
T1/2	Half-life	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	Up to 20 months
Overall Response Rate (ORR)	Defined as complete response (CR) + partial response (PR)	Up to 20 months
AUC0-inf	Area under the serum concentration time curve (AUC) from time 0 extrapolated to infinity	Up to 20 months
ADA	Incidence of anti-drug antibodies (ADA)	Up to 20 months

Collaborators and Investigators

• Sponsor: Shanghai Escugen Biotechnology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: April 10, 2023
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Estimated): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 28, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ESG206-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No