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

B-cell Lymphoid Malignancies Clinical Trial

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(Monoclonal Antibody), ESG206 in Subjects With B-cell Lymphoid Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05822843
• Other study ID #: ESG206-102
• Status: Recruiting
• Phase: Phase 1
• Start date: August 2, 2023
• Est. completion date: March 2025

Study information

• Verified date: April 2023
• Source: Shanghai Escugen Biotechnology Co., Ltd
• Contact: Xiaoyan Xing, PhD
• Phone: +86 21 5855 6098
• Email: xingxiaoyan[@]escugen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 2025
• Est. primary completion date: November 2024
• 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
China	Beijing Cancer Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Escugen Biotechnology Co., Ltd

Country where clinical trial is conducted

China, 

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 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	Cmax	Maximum observed plasma concentration	Up to 20 months
Secondary	AUC0-inf	Area under the serum concentration time curve (AUC) 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 Rate (ORR)	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 (ADA)	Up to 20 months