Study of IMC-I109V in Non-cirrhotic HBeAg-negative Chronic HBV Infection (NCT05867056) | Clinical Trial Compass
WithdrawnPhase 1
Study of IMC-I109V in Non-cirrhotic HBeAg-negative Chronic HBV Infection
Stopped: Enrollment into the phase 2 portion was never initiated.
United States, Australia, Denmark0Started 2020-08-12
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* 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.…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Parts 1, 2, and 3: Incidence and treatment-emergent adverse events (TEAEs)
Timeframe: Up to 30 days after the last infusion of study treatment
2
Parts 1, 2, and 3: Incidence of serious adverse events (SAEs)
Timeframe: Up to 30 days after the last infusion of study treatment
3
Parts 1, 2, and 3: Incidence of adverse events (AEs) leading to treatment discontinuation
Timeframe: Up to 30 days after the last infusion of study treatment
4
Parts 1, 2, and 3: Incidence of dose-limiting toxicities (DLTs)
Timeframe: Up to 30 days after the last infusion of study treatment
5
Parts 1, 2, and 3: Changes in Vital Signs
Timeframe: Up to 30 days after the last infusion of study treatment
6
Parts 1, 2, and 3: Changes in electrocardiogram
Timeframe: Up to 30 days after the last infusion of study treatment
7
Parts 1, 2, and 3: Change in safety laboratory parameters