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WITHDRAWNPHASE1

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

NCT05867056•Immunocore Ltd

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Parts 1 and 2:
•≥18 to 65 years old at time of informed consent
•HLA-A\*02:01 positive
•Documented evidence of CHB based on one of the following: a. Positive HBsAg and HBV DNA at least 6 months prior to the Screening visit; OR b. Historical liver biopsy consistent with CHB infection.
•Have been receiving entecavir and/or tenofovir (including tenofovir alafenamide) for ≥12months prior to screening and are willing to continue.
•HBV DNA negative at screening
•No history of liver cirrhosis AND prior assessment of fibrosis demonstrating non-cirrhotic status at screening
•Participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the trial screening date until 3 months after the final dose of the study intervention or longer if required by local regulations
•Part 3:
•≥18 years old at time of informed consent
+11 more criteria

Exclusion Criteria

•Parts 1 and 2:
•Pregnant or lactating persons
•Known co-infection with any of the following: HIV, Hepatitis C virus, OR Hepatitis D virus
•Changes in HBeAg status within 3 months prior to the screening visit
•Known HBV genotype A
•Gilbert's syndrome
•Any known pre-existing medical or psychiatric condition that could interfere with the participant's ability to provide informed consent or participate in study conduct, or that may confound study findings including, but not limited to: Immunologically-mediated disease, e.g. inflammatory bowel disease (Crohn's disease, ulcerative colitis), rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, scleroderma, or sarcoidosis within 5 years of the screening visit.
•Current or history of any clinically significant cardiac abnormalities/dysfunction, e.g. congestive heart failure, myocardial infarction ≤6 months prior to the screening visit, pulmonary hypertension, complex congenital heart disease, significant arrhythmia, or active cardiac ischemia.
•Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding esophageal varices, hepatorenal syndrome, or hepatic encephalopathy.
•Significant immunosuppression from, but not limited to immunodeficiency conditions such as common variable hypogammaglobulinemia
+23 more criteria

Locations (15)

University of Southern California Keck School of Medicine

Los Angeles, California, United States

University Hospitals Cleveland Medical Center Case Western Reserve

Cleveland, Ohio, United States

St. Vincent's Hospital

Fitzroy, Australia

The Alfred Centre

Melbourne, Australia

Aarhus University

Aarhus, Denmark

Queen Mary Hospital

Hong Kong, Hong Kong

ARENSIA Exploratory Medicine Research Clinic

Bucharest, Romania

Pusan National University Hospital

Busan, South Korea

Hospital Universitari Vall d'Hebron de Barcelona

Barcelona, Spain

Hospital Ramón and Cajal

Madrid, Spain

Key Dates

Start Date

August 12, 2020

Primary Completion Date

September 10, 2024

Completion Date

December 15, 2024

Last Updated

October 15, 2024

Conditions

Hepatitis B, Chronic

Interventions

IMC-I109V Single Ascending Dose

DRUG

IMC-I109V Multiple Ascending Doses

DRUG

HBV HCC Module MAD

DRUG

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

NCT04166266

Hepatitis D, ChronicHepatitis B, Chronic

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RECRUITING

Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion

NCT06550622

Hepatitis B, Chronic

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RECRUITINGEARLY_PHASE1

Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion

Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection

Effectiveness of Antiviral Treatment in Cirrhotic Patients with Low-level Hepatitis B Virus DNA Levels