Hepatitis B, ChronicPhase 1NCT05867056
Study of IMC-I109V in Non-cirrhotic HBeAg-negative Chronic HBV Infection
A Phase 1 study testing IMC-I109V Single Ascending Dose, IMC-I109V Multiple Ascending Doses and HBV HCC Module MAD in people with Hepatitis B, Chronic, run by Immunocore Ltd at 15 sites in 9 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- IMC-I109V Single Ascending Dose, IMC-I109V Multiple Ascending Doses and HBV HCC Module MAD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 15 sitesin 9 countries
- Study dates
- 12 Aug 2020to 15 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 34Show fewer
- 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
- Active hepatitis C virus (HCV) infection
- Untreated HIV infection
- Significant secondary malignancy
- Clinically significant lung, heart, or autoimmune disease
- Ongoing requirement for immunosuppressive treatment
- Prior solid organ or bone marrow transplant
- Hypersensitivity to study drug or excipients, or pre-medications
- Systemic antibiotics, vaccines or major surgery within 2-4 weeks prior to the first dose of study intervention
- Out-of-range laboratory values, including ALT or AST > 3x upper limit of normal (ULN), total bilirubin and direct bilirubin > 1.5x ULN, Albumin ≤ 28 g/L, International normalized ratio (INR) > 1.3
Trial locations and contacts
15 sites in 9 countries.
15 sites in 9 countries
United Kingdom3 sites
Guy's Hospital, Dept. of Infectious Disease
London, SE1 9RT
Chelsea and Westminster Hospital, Research and Development, Clinical Trials Facility
London, SW10 9NH
Nottingham University Hospitals NHS Trust Biomedical Research Centre
Nottingham, NG7 2UH
United States2 sites
University Hospitals Cleveland Medical Center Case Western Reserve
Cleveland, Ohio, 44106
University of Southern California Keck School of Medicine
Los Angeles, California, 90033
Australia2 sites
St. Vincent's Hospital
Fitzroy, 3065
The Alfred Centre
Melbourne, VIC 3004
Spain2 sites
Hospital Universitari Vall d'Hebron de Barcelona
Barcelona, 08035
Hospital Ramón and Cajal
Madrid, 28034
Taiwan2 sites
Kaohsiung Medical University Chung-Ho
Kaohsiung City, 80756
Taipei Veterans General Hospital
Taipei, 112
About this study
Official title: An Open-label Study Evaluating the Safety, Antiviral Activity, and Pharmacokinetics of IMC-I109V in HLA-A*02:01 Positive Participants With Chronic HBV Infection Who Are Non-Cirrhotic, Hepatitis B e Antigen-negative, and Virally Suppressed
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.
Read the detailed 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.
- Conditions
- Hepatitis B, Chronic
- Being tested
- IMC-I109V Single Ascending Dose, IMC-I109V Multiple Ascending Doses, HBV HCC Module MAD
- Keywords
- HBeAg negative, HLA-A*02;01 Positive, T Cell Receptor (TCR)
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMC-I109V Single Ascending DoseDrug
Also called SAD
Single dose administration of IMC-I109V
IMC-I109V Multiple Ascending DosesDrug
Also called MAD
Multidose administration of IMC-I109V
HBV HCC Module MADDrug
Multidose administration of IMC-I109V
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Single Ascending Dose (SAD) | Experimental | 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. Receives: Drug: IMC-I109V Single Ascending Dose |
| Part 2: Multiple Ascending Doses (MAD) | Experimental | 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. Receives: Drug: IMC-I109V Multiple Ascending Doses |
| Part 3: HBV HCC Module MAD | Experimental | 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. Receives: Drug: HBV HCC Module MAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts 1, 2, and 3: Incidence and treatment-emergent adverse events (TEAEs)
Measured: Up to 30 days after the last infusion of study treatment
Parts 1, 2, and 3: Incidence of serious adverse events (SAEs)
Measured: Up to 30 days after the last infusion of study treatment
Parts 1, 2, and 3: Incidence of adverse events (AEs) leading to treatment discontinuation
Measured: Up to 30 days after the last infusion of study treatment
Parts 1, 2, and 3: Incidence of dose-limiting toxicities (DLTs)
Measured: Up to 30 days after the last infusion of study treatment
Parts 1, 2, and 3: Changes in Vital Signs
Number of participants with, and rate of, Grade 1, Grade 2, Grade 3, and Grade 4 (as applicable per NCI CTCAE v5.0) vital sign abnormalities.
Measured: Up to 30 days after the last infusion of study treatment
Parts 1, 2, and 3: Changes in electrocardiogram
QTcF interval absolute values and changes from baseline.
Measured: Up to 30 days after the last infusion of study treatment
Parts 1, 2, and 3: Change in safety laboratory parameters
Number of participants with, and rate of, Grade 1, Grade 2, Grade 3, and Grade 4 (as applicable per NCI CTCAE v5.0) laboratory abnormalities.
Measured: Up to 30 days after the last infusion of study treatment
Secondary outcomes (13)
Parts 1, 2, and 3: Maximum drug concentration (Cmax)
Measured: At designated timepoints up to 162 days post-dose
Parts 1, 2, and 3: Area under the plasma concentration versus time curve (AUC)
Measured: At designated timepoints up to 162 days post-dose
Parts 1, 2, and 3: The time to reach maximum drug concentration (Tmax)
Measured: At designated timepoints up to 162 days post-dose
Parts 1, 2, and 3: The elimination half-life (t1/2)
Measured: At designated timepoints up to 162 days post-dose
Parts 1, 2, and 3: Incidence of anti-IMC-109V antibody formations
Measured: At designated timepoints up to 162 days post-dose
Parts 1, 2, and 3: Antiviral Effects: HBsAg change from baseline
Measured: Up to 280 days post-dose
Parts 1, 2, and 3: Antiviral Effects: HBcrAg change from baseline
Measured: Up to 280 days post-dose
Parts 1, 2, and 3: Antiviral Effects: HBV RNA change from baseline
Measured: Up to 280 days post-dose
Parts 1, 2, and 3: Antiviral Effects: HBsAb change from baseline
Measured: Up to 280 days post-dose
Part 3 only: Objective response rate (ORR) as determined by RECIST v1.1 as assessed by the Investigator
Measured: Up to ~52 months
Part 3 only: Overall survival (OS) as determined by RECIST v1.1 as assessed by the Investigator
Measured: Up to ~52 months
Part 3 only: Progression-free survival (PFS) as determined by RECIST v1.1 as assessed by the Investigator
Measured: Up to ~52 months
Part 3 only: Duration of response (DOR) as determined by RECIST v1.1 as assessed by the Investigator
Measured: Up to ~52 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start12 Aug 2020
- Primary completion10 Sep 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Why it stopped: Enrollment into the phase 2 portion was never initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Participants will receive a single dose of IMC-I109V-101 in Part 1 (SAD) and 24 weekly doses in Part 2 (MAD). Participants in Part 3 will receive weekly doses of IMC-I109V until disease progression, unacceptable toxicity, or other reason for treatment discontinuation occurs.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunocore Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867056
- Sponsor's protocol ID
- IMC-I109V-101
- Other IDs
- 2019-004212-64, 2019
- Status last verified
- Oct 2024
- First submitted
- 12 Apr 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study Evaluating the Safety, Antiviral Activity, and Pharmacokinetics of IMC-I109V in HLA-A*02:01 Positive Participants With Chronic HBV Infection Who Are Non-Cirrhotic, Hepatitis B e Antigen-negative, and Virally Suppressed
- ClinicalTrials.gov ID
- NCT05867056
- Acronym / sponsor ID
- IMC-I109V-101
- Conditions
- Hepatitis B, Chronic
- Keywords
- HBeAg negative, HLA-A*02;01 Positive, T Cell Receptor (TCR)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrollment into the phase 2 portion was never initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Immunocore LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 10 Sep 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will receive a single dose of IMC-I109V-101 in Part 1 (SAD) and 24 weekly doses in Part 2 (MAD). Participants in Part 3 will receive weekly doses of IMC-I109V until disease progression, unacceptable toxicity, or other reason for treatment discontinuation occurs.
| Arm | Type | Receives |
|---|---|---|
| Part 1: Single Ascending Dose (SAD) | Experimental | Drug: IMC-I109V Single Ascending DoseSAD 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. |
| Part 2: Multiple Ascending Doses (MAD) | Experimental | Drug: IMC-I109V Multiple Ascending DosesMAD 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. |
| Part 3: HBV HCC Module MAD | Experimental | Drug: HBV HCC Module MADEnrollment 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- ≥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
Key exclusion criteria (34 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMC-I109V Single Ascending DoseAlso: SADSingle dose administration of IMC-I109V | Drug | Part 1: Single Ascending Dose (SAD) |
| IMC-I109V Multiple Ascending DosesAlso: MADMultidose administration of IMC-I109V | Drug | Part 2: Multiple Ascending Doses (MAD) |
| HBV HCC Module MADMultidose administration of IMC-I109V | Drug | Part 3: HBV HCC Module MAD |
Primary outcome
Parts 1, 2, and 3: Incidence and treatment-emergent adverse events (TEAEs)
Time frame: Up to 30 days after the last infusion of study treatment
Parts 1, 2, and 3: Incidence of serious adverse events (SAEs)
Time frame: Up to 30 days after the last infusion of study treatment
Parts 1, 2, and 3: Incidence of adverse events (AEs) leading to treatment discontinuation
Time frame: Up to 30 days after the last infusion of study treatment
Parts 1, 2, and 3: Incidence of dose-limiting toxicities (DLTs)
Time frame: Up to 30 days after the last infusion of study treatment
Parts 1, 2, and 3: Changes in Vital Signs
Time frame: Up to 30 days after the last infusion of study treatment
Number of participants with, and rate of, Grade 1, Grade 2, Grade 3, and Grade 4 (as applicable per NCI CTCAE v5.0) vital sign abnormalities.
Parts 1, 2, and 3: Changes in electrocardiogram
Time frame: Up to 30 days after the last infusion of study treatment
QTcF interval absolute values and changes from baseline.
Parts 1, 2, and 3: Change in safety laboratory parameters
Time frame: Up to 30 days after the last infusion of study treatment
Number of participants with, and rate of, Grade 1, Grade 2, Grade 3, and Grade 4 (as applicable per NCI CTCAE v5.0) laboratory abnormalities.
13 secondary outcomes
Parts 1, 2, and 3: Maximum drug concentration (Cmax)
Time frame: At designated timepoints up to 162 days post-dose
Parts 1, 2, and 3: Area under the plasma concentration versus time curve (AUC)
Time frame: At designated timepoints up to 162 days post-dose
Parts 1, 2, and 3: The time to reach maximum drug concentration (Tmax)
Time frame: At designated timepoints up to 162 days post-dose
Parts 1, 2, and 3: The elimination half-life (t1/2)
Time frame: At designated timepoints up to 162 days post-dose
Parts 1, 2, and 3: Incidence of anti-IMC-109V antibody formations
Time frame: At designated timepoints up to 162 days post-dose
Parts 1, 2, and 3: Antiviral Effects: HBsAg change from baseline
Time frame: Up to 280 days post-dose
Parts 1, 2, and 3: Antiviral Effects: HBcrAg change from baseline
Time frame: Up to 280 days post-dose
Parts 1, 2, and 3: Antiviral Effects: HBV RNA change from baseline
Time frame: Up to 280 days post-dose
Parts 1, 2, and 3: Antiviral Effects: HBsAb change from baseline
Time frame: Up to 280 days post-dose
Part 3 only: Objective response rate (ORR) as determined by RECIST v1.1 as assessed by the Investigator
Time frame: Up to ~52 months
Part 3 only: Overall survival (OS) as determined by RECIST v1.1 as assessed by the Investigator
Time frame: Up to ~52 months
Part 3 only: Progression-free survival (PFS) as determined by RECIST v1.1 as assessed by the Investigator
Time frame: Up to ~52 months
Part 3 only: Duration of response (DOR) as determined by RECIST v1.1 as assessed by the Investigator
Time frame: Up to ~52 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMC-I109V Single Ascending Dose, IMC-I109V Multiple Ascending Doses and HBV HCC Module MAD in people with Hepatitis B, Chronic, run by Immunocore Ltd at 15 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United Kingdom, United States, Australia, Spain, Taiwan and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parts 1, 2, and 3: Incidence and treatment-emergent adverse events (TEAEs) (time frame: Up to 30 days after the last infusion of study treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.