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

Withdrawn before enrolling · Phase 1

Conditions studied: Hepatitis B, Chronic

In brief

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.

Key facts

Study ID: NCT05867056
Run by: Immunocore Ltd
People needed: 0
Starts: 2020-08-12
Expected to finish: 2024-12-15
Last updated by the study team: 2024-10-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
HLA-A*02:01 positive
ECOG ≤1
Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology / cytology, or clinically by American Association for the Study of Liver Diseases criteria
Failed or intolerant of ≥1 systemic therapy
At least one measurable lesion (per RECIST 1.1) which is either not previously treated or, if treated, has clearly progressed prior to enrollment
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
Life expectancy >3 months from time of enrolment
Have compensated cirrhosis with a Child-Pugh score ≤ 7 (A or B7)
On entecavir and/or tenofovir (disoproxil fumarate or alafenamide) with HBV DNA <100IU/ml at screening; willingness to continue for at least 6 months after the last dose of study drug
Quantitative HBV surface antigen ≤ 5,000 IU/mL 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

You may not qualify if…

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
Evidence of active or suspected malignancy, or a history of malignancy ≤3 years prior to the screening visit (except adequately treated carcinoma in situ, basal cell carcinoma of the skin, or stage 0 HCC that has been treated). NOTE: Participants under evaluation for malignancy are not eligible
Receiving or planning to receive systemic immunosuppressive medications during the study or ≤ 2 months prior to Day1, including but not limited to prednisone >10 mg/day (or equivalent), methotrexate, cyclosporine, or interferon. NOTE: Local steroid therapy is allowed (eg, inhaled, otic, ophthalmic, or intra-articular medications)
Use of any live vaccines against infectious diseases within 4 weeks of the first planned administration of study intervention or use of any non-live vaccines against infectious diseases within 2 weeks of the first planned administration of study intervention.
Treatment with any investigational drug or enrollment in any other clinical study ≤ 3 months prior to Day1, or at any time during participation in the study.
Clinical diagnosis of substance abuse with alcohol, narcotics, or cocaine ≤12 months prior to the screening visit, except for those participants monitored in an opioid substitution maintenance program.
Part 3:
Pregnant or lactating persons
Untreated or symptomatic CNS metastases
Significant ongoing toxicity from prior anticancer treatment -
Ascites requiring recurrent paracentesis
Inadequate washout from prior anticancer therapy
Prior cellular therapy for HBV-associated HCC
Known HBV genotype A
Decompensated liver disease
Surgical intervention or local / loco-regional therapy for HBV HCC within 28 days of planned first dose of study treatment

Where it is running

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
Kaohsiung Medical University Chung-Ho — Kaohsiung City, Taiwan
Taipei Veterans General Hospital — Taipei, Taiwan
Guy's Hospital, Dept. of Infectious Disease — London, United Kingdom
Chelsea and Westminster Hospital, Research and Development, Clinical Trials Facility — London, United Kingdom
Nottingham University Hospitals NHS Trust Biomedical Research Centre — Nottingham, United Kingdom

Full record on ClinicalTrials.gov

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