Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05867056
Study type Interventional
Source Immunocore Ltd
Contact Immunocore Medical Information
Phone 844-466-8661
Email medical.information@immunocore.com
Status Recruiting
Phase Phase 1
Start date August 12, 2020
Completion date December 15, 2024

See also
  Status Clinical Trial Phase
Completed NCT03272009 - Evaluation of the Safety and Pharmacology of EYP001 in HBV Subjects Phase 1
Recruiting NCT01456312 - HBsAg Related Response Guided Therapy Phase 4
Terminated NCT01886300 - An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive Chronic Hepatitis B in Vietnam N/A
Completed NCT00962975 - A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies Phase 1
Completed NCT01023230 - A Study to Assess DV-601 in Subjects With Chronic Hepatitis B Phase 1
Terminated NCT00460850 - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B. Phase 4
Completed NCT00536263 - PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327) Phase 3
Completed NCT03681132 - The Norwegian Nucleoside Analogue Stop Study Phase 4
Active, not recruiting NCT05473806 - Effects of Pioglitazone and Evogliptin on Hepatic Fibrosis in Patients With Chronic Hepatitis B With Type 2 Diabetes Phase 4
Withdrawn NCT01179594 - A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B. Phase 4
Recruiting NCT05057065 - A Clinical Research on Disease Progression and Intervention of Chronic HepatitisB
Completed NCT04439539 - A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection Phase 2
Withdrawn NCT03125213 - A Study Evaluating AL-3778 in Combination With Peginterferon Alpha-2a in Chronic Hepatitis B Subjects Phase 2
Active, not recruiting NCT04782375 - Safely Discontinue Antiviral Treatment in Patients With Chronic Hepatitis B Phase 4
Withdrawn NCT05550519 - A Study in Chronic Hepatitis B e-Antigen Negative Participants After Discontinuation of Nucleos(t)Ide Analog (NA) Treatment Early Phase 1
Completed NCT02693652 - A Study to Evaluate the Safety and Efficacy of Therapeutic Hepatitis B Vaccine Phase 1/Phase 2
Enrolling by invitation NCT04160897 - Risk of Hepatocellular Carcinoma in Patients Treated With ETV vs TDF for Chronic Hepatitis B With Compensated Cirrhosis
Active, not recruiting NCT02588937 - Active Drug Comparative Trial to Evaluate the Antiviral Activity and Safety in Chronic Hepatitis B Patients Phase 4
Completed NCT02612506 - Safety and Pharmacokinetic Study of Hepalatide(L47) in Healthy Volunteers Phase 1
Recruiting NCT02327416 - A Prospective Clinical Trial in Chronic Hepatitis B Patients NAs (Nucleotides or Nucleosides) Experienced (Anchor Study) Phase 3