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

Sponsor

Shanghai Escugen Biotechnology Co., Ltd (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05822843

Collaborator

(none)

Enrollment

Arms

20.1

Anticipated Duration (Months)

Study Details

Study Description

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, and preliminary efficacy and to establish the MTD, if any, and RP2D(s) of ESG206 in adult subjects with B lymphoid malignancies.

Condition or Disease	Intervention/Treatment	Phase
B-cell Lymphoid Malignancies	Drug: ESG206	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A 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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Percentage of Participants Experiencing Any Treatment Emergent Adverse Events [First dose date up to last dose plus 30 days]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shanghai Escugen Biotechnology Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Escugen Biotechnology Co., Ltd

ClinicalTrials.gov Identifier:

NCT05822843

Other Study ID Numbers:

ESG206-102

First Posted:

Apr 21, 2023

Last Update Posted:

Apr 21, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Apr 21, 2023