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

B-cell Lymphoid Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05263739
• Other study ID #: ESG206-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 2024
• Est. completion date: May 2025

Study information

• Verified date: April 2023
• Source: Shanghai Escugen Biotechnology Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: May 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• B-cell Lymphoid Malignancies
• Neoplasms

Intervention

Drug:
• ESG206
Administered via intravenous (IV) infusion

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Escugen Biotechnology Co., Ltd	Escugen (Australia) Biotechnology Pty Ltd

Outcome

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