NCT05867056

Study of IMC-I109V in Non-cirrhotic HBeAg-negative Chronic HBV Infection

An Open-label Study Evaluating the Safety, Antiviral Activity, and Pharmacokinetics of IMC-I109V in HLA-A*02:01 Positive Participants With Chronic HBV Infection Who Are Non-Cirrhotic, Hepatitis B e Antigen-negative, and Virally Suppressed

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Immunocore Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

IMC-I109V is an immune-mobilizing monoclonal T cell receptor (TCR) against viruses (ImmTAV®), a new class of bispecific protein therapeutics designed for the treatment of chronic hepatitis B virus (HBV) infection (CHB). This is the first in-human study of IMC-I109V in persons with CHB.

Detailed description

IMC-I109V-101 is a first-in-human (FIH) study designed to assess the safety, tolerability, and pharmacokinetic (PK) profile of IMC-I109V in single and multiple dose regimens and to provide a preliminary assessment of antiviral activity, when administered to virally suppressed hepatitis B e-antigen (HBeAg)-negative participants receiving long-term NA therapy. The aim of this study is to identify safe, tolerable, and clinically active dose (CAD) regimens of IMC-I109V for further clinical development. The IMC-I109V study is divided into 3 main parts: Part 1 - Single Ascending Dose (SAD); Part 2 - Multiple Ascending Dose (MAD), in HBeAg-negative CHB; Part 3 will evaluate safety, tolerability, antiviral activity, PK and anti-tumor efficacy of Multiple Ascending Doses of IMC-I109V in participants with HBV-associated hepatocellular carcinoma (HBV HCC) who are virally suppressed on NA therapy.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	IMC-I109V Single Ascending Dose	Single dose administration of IMC-I109V
DRUG	IMC-I109V Multiple Ascending Doses	Multidose administration of IMC-I109V
DRUG	HBV HCC Module MAD	Multidose administration of IMC-I109V

Timeline

• Start date: 2020-08-12
• Primary completion: 2024-09-10
• Completion: 2024-12-15
• First posted: 2023-05-19
• Last updated: 2024-10-15

Locations

15 sites across 9 countries: United States, Australia, Denmark, Hong Kong, Romania, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study