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Monoclonal Antibodies
IMC-I109V for Chronic Hepatitis B
Phase 1
Recruiting
Research Sponsored by Immunocore Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~52 months
Awards & highlights
Study Summary
This trial tests a new therapy for chronic hepatitis B. It's a bispecific protein designed to mobilize the immune system to fight the virus.
Who is the study for?
This trial is for adults over 18 with non-cirrhotic, HBeAg-negative chronic hepatitis B who've been on entecavir/tenofovir for at least a year and are HBV DNA negative. They must be HLA-A*02:01 positive without significant heart issues, immunosuppression, or co-infection with HIV/HCV/HDV. Pregnant/lactating individuals and those with recent substance abuse or other conditions that could affect the study are excluded.Check my eligibility
What is being tested?
The trial tests IMC-I109V in two forms: single ascending dose and multiple ascending doses. It's an ImmTAV® therapeutic designed to mobilize immune T cells against viruses, specifically targeting chronic hepatitis B virus (HBV) infection.See study design
What are the potential side effects?
Potential side effects aren't specified but may include typical reactions to monoclonal antibodies such as infusion-related reactions, fatigue, allergic responses, or autoimmune-like symptoms due to immune system activation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to ~52 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~52 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Parts 1, 2, and 3: Change in safety laboratory parameters
Parts 1, 2, and 3: Changes in Vital Signs
Parts 1, 2, and 3: Changes in electrocardiogram
+4 moreSecondary outcome measures
Part 3 only: Duration of response (DOR) as determined by RECIST v1.1 as assessed by the Investigator
Part 3 only: Objective response rate (ORR) as determined by RECIST v1.1 as assessed by the Investigator
Part 3 only: Overall survival (OS) as determined by RECIST v1.1 as assessed by the Investigator
+10 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Part 3: HBV HCC Module MADExperimental Treatment1 Intervention
Enrollment into Part 3 may begin at the discretion of the Sponsor and will involve a maximum 42-day screening period, a treatment period comprising weekly administration of the target dose until the criteria for treatment discontinuation are met. Visits will take place on Day 1-2 and Day 8, Week 3 (Day 15), with this cycle being repeated until treatment stops, then 30 and 90 days post-last dose, then every 3 months after last dose, after which there will be a safety follow-up period of 30 days.
Group II: Part 2: Multiple Ascending Doses (MAD)Experimental Treatment1 Intervention
MAD will be approximately 54 weeks for each participant, comprising a maximum 42-day screening period, a 24-week treatment period involving weekly administration of IMC-I109V, and a 24-week follow-up period, with a total of 29 visits. Visits will take place on Day -1 and Days 1, 3 and 8, Weeks 3 (Day 15) through 24, Weeks 28, 36, 48 and 49. Participants who have achieved HBsAg <100 IU/mL at end of Week 24 may be considered for further study treatments of up to Week 48 and follow-up visits every 12 weeks to Week 72. Treatment will be discontinued at Week 16 in participants who have not shown evidence of a response to IMC-I109V, in order to minimize unnecessary drug exposure in participants who are unlikely to achieve reductions in viral biomarkers with further doses.
Group III: Part 1: Single Ascending Dose (SAD)Experimental Treatment1 Intervention
SAD will be approximately 10 weeks for each participant, comprising a maximum 42-day screening period, a 1-day treatment period involving a single administration of IMC-I109V and a 28-day follow-up period, for a total of 8 visits. Visits will take place on Day -1 and Days 1, 2, 3, 8, 15, 22, and 29. Follow-up may be extended in participants who achieve a decrease in HBsAg of > 0.5 log10 IU/mL at Day 29.
Find a Location
Who is running the clinical trial?
Immunocore LtdLead Sponsor
13 Previous Clinical Trials
3,589 Total Patients Enrolled
Lucy DorrellStudy DirectorImmunocore Ltd
2 Previous Clinical Trials
51 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have HIV, Hepatitis C, or Hepatitis D.My hepatitis B virus is genotype A.I have Gilbert's syndrome.I don't have any health or mental conditions that could affect my study participation.I have been on entecavir or tenofovir for over a year and will continue.I have severe liver problems, such as fluid in the abdomen or bleeding in the stomach.I haven't had cancer, except for specific non-aggressive types, in the last 3 years.I am 18 years old or older.I am HLA-A*02:01 positive.My liver does not have cirrhosis and a test confirmed this before screening.I have a condition that significantly weakens my immune system.I am taking or plan to take strong immune system medications soon.I do not have any serious heart conditions or recent heart attacks.I have not received live vaccines within 4 weeks or non-live vaccines within 2 weeks before starting the study treatment.I have had chronic hepatitis B for at least 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2: Multiple Ascending Doses (MAD)
- Group 2: Part 3: HBV HCC Module MAD
- Group 3: Part 1: Single Ascending Dose (SAD)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Hepatitis B Patient Testimony for trial: Trial Name: NCT05867056 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
May I be enrolled in this experiment?
"This clinical trial has 108 openings and is seeking volunteers with chronic hepatitis b who are between 18-65 years old."
Answered by AI
Is the research study recruiting elderly participants?
"As per the study's stated rules, patients must be no younger than 18 and not exceed 65 years of age to qualify for enrollment."
Answered by AI
Are there active enrolment opportunities for this trial?
"The clinicaltrial.gov page confirms that this trial is currently in the recruitment phase, having been posted on August 12th 2020 and last amended on May 10th 2023."
Answered by AI
Can you quantify the risk associated with Part 1: Single Ascending Dose (SAD) for participants?
"Our team at Power determined that the safety of Part 1: Single Ascending Dose (SAD) is a score of 1 due to its Phase 1 status, indicating there are only limited data demonstrating efficacy and safeguarding."
Answered by AI
How many trial locations have been established for this research?
"Patients can be recruited for this clinical trial from 15 different locations, some of which include New york Presbyterian Hospital Cornell University Joan & Sanford I. Weill Medical College in New York, University Hospitals Cleveland Medical Center Case Western Reserve in Cleveland, and St. Vincent's Hospital in Fitzroy. There are numerous other recruiting sites as well."
Answered by AI
How many subjects are enrolled in this experiment?
"Affirmative. According to the information found on clinicaltrials.gov, this medical trial is actively seeking out participants. It was published online on August 12th 2020 and has been recently updated as of May 10th 2023. 108 individuals across 15 different sites are being sought for inclusion in the study."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
University of Southern California Keck School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Well I guess my girlfriend (ex) gave it to me I'm not sure if I'm chronic or not but I've had no treatment and I cancould really use the money and rid myself of this.
PatientReceived 2+ prior treatments
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