Phase 1/2 study of IMC-I109V in non-cirrhotic HBeAg-negative chronic hepatitis B (HBV) infectio

Phase 1

Recruiting

• Conditions: HBeAg-negative chronic HBV infection; Infection - Other infectious diseases; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12620000403932
• Lead Sponsor: Immunocore Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-25
• Last Update Posted: 5 December 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Aged 18 to 55 years inclusive, at the time of signing the informed consent.
2. HLA-A*02:01 positive (central laboratory testing)
3. 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 available.
4. If previously HBeAg-positive, participants must be HBeAg-negative at the screening
visit and have historical HBeAg-negative status greater than 3 months prior to the screening visit available for review.
5. Have been receiving entecavir and/or tenofovir (including tenofovir alafenamide) for
greater than or equal to 12 months prior to screening and are willing to continue.
6. HBV DNA negative at screening.
7. Quantitative HBV surface antigen less than or equal to 1000 IU/mL at the screening visit. Participants with HBsAg levels greater than or equal to 1000 IU/mL and less than or equal to 3000 IU/mL may be eligible after consultation with, and approval by, the Sponsor’s Medical Monitor.
8. All participants must have no history of liver cirrhosis AND prior assessment of fibrosis demonstrating non-cirrhotic status at screening. as defined by one of the following:
9. a. Liver biopsy demonstrating a Metavir Fibrosis Score of F0-2 (or equivalent);
OR
b. Fibroscan® result of less than 9 kPa.
10. Male and female participants of childbearing potential who are sexually active with a nonsterilized partner must agree to use highly effective methods of birth control from the trial screening date until 6 months after the final dose of the study intervention.
11. Capable of giving signed informed consent.

Exclusion Criteria

Participants are excluded from the study if ANY of the following criteria apply:
1. Known co-infection with any of the following:
a. HIV
b. Hepatitis C virus OR
c. Hepatitis D virus
2. Changes in HBeAg status within 3 months prior to the screening visit.
3. Known HBV genotype A
4. History of HCC
5. Gilbert’s syndrome
6. 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.
7. Significant immunosuppression from, but not limited to immunodeficiency conditions
such as common variable hypogammaglobulinemia.
8. Evidence of active or suspected malignancy, or a history of malignancy less than or equal to 3 years prior to the screening visit (except adequately treated carcinoma in situ and basal cell carcinoma of the skin).
9. Known or suspected hypersensitivity or previous severe reactions to any of the constituents of IMC-I109V, or the drugs used in the pre-treatment regimen (eg, dexamethasone, ibuprofen and paracetamol).
10. Pregnant or lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified