Study of CT-01 as Monotherapy and Combination Therapy in Subjects With Intermediate or Advanced H… (NCT06994572) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Study of CT-01 as Monotherapy and Combination Therapy in Subjects With Intermediate or Advanced Hepatocellular Carcinoma
141 participantsStarted 2025-05-26
Plain-language summary
This is a Phase 1, open-label, multicenter, dose-escalation and dose-expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CT-01, administered either as monotherapy or in combination with everolimus. The study population includes subjects with intermediate or advanced hepatocellular carcinoma (HCC) who have progressed on, or are intolerant to, at least one prior line of systemic treatment. All available standard-of-care therapies should have been received, if deemed appropriate by the investigator (unless contraindicated or considered inappropriate by the treating physician). Eligible subjects are classified as Barcelona Clinic Liver Cancer (BCLC) stage B or C and must not be amenable to curative treatment approaches. Only subjects with preserved liver function (Child-Pugh Class A, score 5-6) at screening are eligible. Approximately 141 participants will be enrolled across 20 sites in Europe (France, Spain, and Germany).
Who can participate
Age range
18 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
. Documented to be surgically sterile or postmenopausal, or
. Practicing true abstinence for at least 28 days prior to investigational medical product (IMP) administration and for 6 months after the treatment period and having a negative pregnancy test prior dosing, or
. Willing and able to comply with two forms of contraception methods, including one physical barrier (condom or diaphragm) plus another method, such as adequate hormonal method (eg, contraceptive implants, injectables, oral contraceptives) or nonhormonal methods (eg, intrauterine device, spermicidal) during and for 6 months after the treatment period and having a negative pregnancy test prior dosing. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
. Documented to be surgically sterile (vasectomy), or
. Practicing true abstinence during the treatment period and for 6 months after the last IMP administration, or
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
Number of participants with treatment-emergent adverse events (TEAEs) during CT-01 monotherapy
Timeframe: Up to 12 months
2
Maximum tolerated dose (MTDm) of CT-01 monotherapy
Timeframe: Up to 12 months
3
Number of participants with treatment-emergent adverse events (TEAEs) during CT-01 and everolimus combination therapy
Timeframe: Up to 12 months
4
Maximum tolerated dose (MTDc) of CT-01 in combination with everolimus
. Willing and able to comply with two forms of contraception methods, including one physical barrier (condom or diaphragm) during the treatment period and for 6 months after the last IMP administration. Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Exclusion criteria
. Patients with acute hepatitis B infection are excluded. Acute Hepatitis B is defined based on the following serology profile: positive hepatitis B surface antigen (HBsAg positive), positive total hepatitis B core antibody (anti-HBc positive), IgM antibody positive to hepatitis B core antigen (IgM anti-HBc positive), and hepatitis B surface antibody negative (anti-HBs negative) test at screening.
. Patients with a past or resolved HBV infection (defined as HBsAg positive and anti-HBc positive) are eligible.
. Patients positive for HCV antibody are eligible only if PCR is negative for HCV ribonucleic acid (RNA).
. Chronic HBV (HBsAg positive, undetectable or low HBV DNA, and normal ALT) is eligible if patients are receiving direct-acting antiviral treatment.
. Patients with resolved hepatitis C infection are eligible. This is defined as undetectable or unquantifiable HCV RNA 12 weeks or longer after treatment completion (defined as a sustained virological response).
. Patients with untreated HCV infection or have not completed treatment for HCV infection.
. Patients with treated HCV infection but with a HCV viral load above the level of quantification.