Hepatocellular Carcinoma (HCC)Phase 1NCT06994572

Study of CT-01 as Monotherapy and Combination Therapy in Subjects With Intermediate or Advanced Hepatocellular Carcinoma

A Phase 1 study testing CT-01 and EVEROLIMUS in people with Hepatocellular Carcinoma (HCC), run by Captor Therapeutics S.A..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatocellular Carcinoma (HCC)
What is being tested?: CT-01 and EVEROLIMUS
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 141 participants
Where: No sites listed yet
Study dates: 26 May 2025to 1 Apr 2030
Phase: Phase 1
Are there results?: Not yet: the study is under way

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Able to understand and willing to provide informed consent and able to comply with the study procedures and restrictions.
Are ≥18 years of age and of any gender at the time of screening.
Have confirmed histological and/or radiological diagnosis of HCC with a Child-Pugh Class A score of 5 to 6 points within 7 days of first dose of study drug.
Has BCLC stage B and are ineligible for or are refractory to locoregional therapy and not amenable to a curative treatment approach, or BCLC stage C and are not amenable to a curative treatment approach.
Have progressed on or are intolerant to ≥1 prior systemic standard of care treatment. All available standard of care treatments should have been received as prior systemic treatment if deemed appropriate by the investigator (unless such treatments are deemed contraindicated or inappropriate by the treating physician).
Have Eastern Cooperative Oncology Group (ECOG) score ≤1.

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Have at least one measurable disease lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and/or modified RECIST (mRECIST), with a minimum of 1 target lesion in the liver at screening.
Female subjects may be enrolled if they refrain from donating eggs (ova, oocytes) for the purpose of reproduction during the treatment period and for 6 months after the treatment period and if they are:
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.
Male subjects with female partners of childbearing potential may be enrolled if they refrain from donating sperm during the treatment period and for 6 months after the last IMP administration and if they are:
Documented to be surgically sterile (vasectomy), or
Practicing true abstinence during the treatment period and for 6 months after the last IMP administration, or
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

Who cannot join

Have not recovered from toxicities to baseline or Grade ≤1 by CTCAE version 5.0 from prior anticancer therapy, except alopecia and sub-optimally treated nausea, vomiting, or diarrhea.
Have a history of liver transplant.
Any other active malignancy at time of screening or diagnosis of another malignancy within 2 years before screening that requires active treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy.
Have central nervous system (CNS) metastases or any other Grade >2 CNS disorder. Subjects with CNS metastases who are stable on their treatment since a minimum of 4 weeks prior to screening are eligible.
Have recent esophageal or gastric variceal bleeding within 4 weeks prior to screening. Subjects with treated, stable, or small varices without bleeding within the 4 weeks prior to screening are eligible.
Have a history of symptomatic ascites requiring paracentesis within the past 3 months prior to screening.

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Have a prior diagnosis of rhabdomyolysis from any cause.
Subjects with known retinal disease (eg, diabetic retinopathy, macular degeneration, retinal detachment/tear, etc).
Have a history of clinically significant cytokine release syndrome as assessed by the treating physician, clinically significant hypotension (defined as a blood pressure [BP] consistently <90/60 mmHg and/or a BP associated with symptoms of hypotension (dizziness, fainting, orthostatic hypotension [systolic BP drop of >20 mmHg or diastolic BP drop of >10 mmHg on orthostasis]), symptomatic hypocalcemia and/or a calcium level <1.5 mmol/L.
Have a history of pneumonitis or pericarditis.
Subjects who are not, in the opinion of the investigator, willing or able to comply with the protocol or who present a contraindication to any study procedure.
Have inadequate hematologic and end-organ function, defined as follows:
Hemoglobin <8.5 g/dL
Absolute neutrophil count <1,500 per mm3
Platelet count <75,000 per mm3
Total bilirubin >2 × ULN for the designated testing laboratory
AST or ALT >5 × ULN
Serum creatinine >1.5 × ULN
International normalized ratio (INR) >1.7 × ULN
Glomerular filtration rate (GFR) < 50 mL/min
Have imaging findings corresponding to HCC with ≥50% liver occupation, or clear invasion into the bile duct.
Have an active infection with the hepatitis B virus (HBV) or hepatitis C virus (HCV).
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.
Have a history of human immunodeficiency virus (HIV) infection.
Have life expectancy shorter than 3 months.
Have received any systemic anticancer treatment or any investigational treatment within 14 days or at least 5 half-lives of the treatment, whichever is shorter, prior to screening.
Are unable to take oral medications.
Have a known malabsorption syndrome.
Applicable to subjects enrolling in Part 2 only:
Are currently receiving treatment with the cytochrome P450 (CYP) 3A4 inhibitors (eg, azoles, clarithromycin, or grapefruit), CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin, or St. John's wort), or p-glycoprotein (P-gp) inhibitors or inducers (eg, verapamil, quinidine, amiodarone, diltiazem, erythromycin, cyclosporine, ketoconazole, ritonavir, or tamoxifen).
Subjects able to receive modified dose of the P-gp or CYP3A4 inhibitors based on everolimus drug label may be eligible at the discretion of the investigator in consultation with the sponsor and Medical Monitor.
Have a known intolerance or hypersensitivity to everolimus, its component (eg, lactose), or other rapamycin derivatives.
Subjects who are planned for elective surgery within 56 days of planned treatment Day 1 are excluded due to the risk of impaired wound healing with everolimus and the requirement to interrupt everolimus treatment per the everolimus SmPC. (Note: subjects who can delay elective surgery beyond Day 56 (Week 8, RECIST version 1.1 assessment) of study treatment are eligible for the study).

About this study

Official title: A Phase 1, Open-Label, Dose Escalation, and Dose Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CT-01 as Monotherapy and Combination Therapy With Everolimus in Subjects With Intermediate or Advanced Hepatocellular Carcinoma (BCLC Stage B or C) With Preserved Liver Function (Child-Pugh Class A)

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).

Read the detailed description

This is an open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of CT-01 in subjects with advanced hepatocellular carcinoma (HCC). The study consists of two sequential parts.

Part 1 investigates CT-01 as monotherapy and includes a dose-escalation phase (Part 1A) followed by a dose-expansion phase (Part 1B). A Bayesian Optimal Interval (BOIN) design will be used, with up to seven predefined dose levels. Additional subjects may be enrolled to backfill dose levels of interest. Treatment will be administered in 28-day cycles, with dose-limiting toxicities (DLTs) assessed during Cycle 1. Dose decisions will be made by an Independent Data Monitoring Committee (IDMC), with input from a Safety Monitoring Committee (SMC).

Part 2 evaluates CT-01 in combination with everolimus and includes a dose-escalation phase (Part 2A) and a dose-expansion phase (Part 2B). Up to four dose levels are planned in Part 2A, with starting doses informed by Part 1 results. As in Part 1, DLTs will be assessed during Cycle 1 and reviewed by the IDMC and SMC.

Conditions: Hepatocellular Carcinoma (HCC)
Being tested: CT-01, EVEROLIMUS
Medical subject headings: Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CT-01Drug
Investigational small-molecule degrader targeting transcription factors in HCC. Used as monotherapy or with everolimus in dose-escalation/expansion settings. Specific to protocol CT-01-CD-1.
EVEROLIMUSDrug
Approved mTOR inhibitor used in combination with CT-01 for HCC in this study. Evaluated for safety, tolerability, and PK/PD in CT-01-CD-1 protocol.

Study groups in NCT06994572
Study group	Role	What they receive
CT-01 PART 1A: Monotherapy - Dose Escalation	Experimental	Subjects receive CT-01 monotherapy at predefined dose levels. Doses assigned according to a dose-escalation protocol. Receives: Drug: CT-01
CT-01 PART 1B: Monotherapy - Dose Expansion	Experimental	Subjects receive CT-01 monotherapy at the selected recommended dose level identified in Part 1A Receives: Drug: CT-01
CT-01 PART 2A: Combotherapy - Dose Escalation	Experimental	Subjects receive CT-01 and everolimus orally once daily in 28-day cycles Receives: Drug: CT-01; Drug: EVEROLIMUS
CT-01 PART 2B: Combotherapy - Dose Expansion	Experimental	Subjects receive CT-01 and everolimus at the recommended combination dose. Receives: Drug: CT-01; Drug: EVEROLIMUS

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with treatment-emergent adverse events (TEAEs) during CT-01 monotherapy
Safety and tolerability of CT-01 will be evaluated by monitoring the incidence of TEAEs, SAEs, AESIs, and TEAEs leading to study discontinuation or death.
Unit of Measure: Number, nature, sverity and relation plausibility of AE
Measured: Up to 12 months
Maximum tolerated dose (MTDm) of CT-01 monotherapy
The MTDm will be determined based on the incidence and type of dose-limiting toxicities (DLTs) during Cycle 1 of CT-01 monotherapy.
Unit of Measure: mg/day
Measured: Up to 12 months
Number of participants with treatment-emergent adverse events (TEAEs) during CT-01 and everolimus combination therapy
Safety and tolerability will be assessed through monitoring of TEAEs, SAEs, AESIs, and TEAEs leading to study discontinuation or death during combination therapy.
Unit of Measure: Number, nature, sverity and relation plausibility of A
Measured: Up to 12 months
Maximum tolerated dose (MTDc) of CT-01 in combination with everolimus
The MTDc will be determined based on the incidence of DLTs during Cycle 1 of the combination therapy.
Unit of Measure: mg/day
Measured: Up to 12 months

Secondary outcomes (22)

Objective response rate (ORR) per RECIST v1.1 and mRECIST for CT-01 monotherapy
Proportion of participants achieving complete or partial response as per RECIST v1.1 and mRECIST.
Unit of Measure: Percentage of participants
Measured: Up to 12 months
Objective response rate (ORR) per RECIST v1.1 and mRECIST for CT-01 and everolimus
Proportion of participants achieving complete or partial response during combination therapy.
Unit of Measure: Percentage of participants
Measured: Up to 12 months
Maximum plasma concentration (Cmax)
Cmax will be determined for CT-01 using non-compartmental analysis. Unit of Measure: ng/mL
Measured: Up to 12 months
Area under the concentration-time curve (AUC)
AUC will be calculated for active metabolite of CT-01 using non-compartmental methods (AUC₀-t and AUC₀-inf).
Unit of Measure: ng·h/mL
Measured: Up to 12 months
Time to maximum concentration (Tmax)
Tmax will be recorded as the time to reach Cmax for CT-01. Unit of Measure: Hours
Measured: Up to 12 months
Change from baseline in MELD-Na score during combination therapy
Change in MELD-Na score (range: typically 6 to 40; higher scores indicate worse liver function) from baseline during CT-01 and everolimus treatment. Unit of Measure: score
Measured: Up to 12 months
Change from baseline in Child-Pugh score during combination therapy
Change in Child-Pugh score (range: 5-15; higher scores indicate worse liver function) from baseline during CT-01 and everolimus treatment.
Unit of Measure: score
Measured: Up to 12 months
Change from baseline in Albumin-Bilirubin (ALBI) score during combination therapy
Change from baseline in ALBI score will be evaluated during CT-01 and everolimus combination therapy. The ALBI score is calculated using serum bilirubin and albumin. Changes from baseline will be summarized by time point. Higher scores indicate worse liver function.
Unit of Measure: score
Measured: Up to 12 months
Change from baseline in lipid profile during combination therapy
Change in serum lipid parameters (total cholesterol, LDL, HDL, triglycerides) from baseline during CT-01 and everolimus treatment.
Unit of measure: mmol/L
Measured: Up to 12 months
Change from baseline in serum glucose levels during combination therapy
Change in blood glucose concentration from baseline during CT-01 and everolimus treatment.
Unit of Measure: mmol/L
Measured: Up to 12 months
Change from baseline in serum alpha-fetoprotein (AFP) levels during combination therapy
Change in serum AFP concentration from baseline during treatment with CT-01 in combination with everolimus. AFP is a tumor marker used in hepatocellular carcinoma.
Unit of Measure: ng/mL
Measured: Up to 12 months
Terminal half-life (T1/2)
T1/2 will be estimated for active metabolite of CT-01 from the log-linear terminal phase of the concentration-time curve.
Unit of Measure: Hours
Measured: Up to 12 months
Title: Maximum plasma concentration (Cmax)
Cmax will be determined for CT-01 in combination with everolimus using non-compartmental analysis.
Unit of Measure: ng/mL
Measured: Up to 12 months
Change from baseline in serum glucose levels during monotherapy
Change in blood glucose concentration from baseline during CT-01 monotherapy. Unit of Measure: mmol/L
Measured: Up to 12 months
Area under the concentration-time curve (AUC)
AUC for active metabolite of CT-01 in combination with everolimus will be calculated using non-compartmental methods.
ng·h/mL
Measured: Up to 12 months
Time to maximum concentration (Tmax)
Tmax will be recorded for CT-01 when administered with everolimus. Unit of Measure: Hours
Measured: Up to 12 months
Terminal half-life (T1/2)
T1/2 will be estimated for active metabolite of CT-01 in combination therapy using non-compartmental analysis.
Unit of Measure: Hours
Measured: Up to 12 months
Change from baseline in lipid profile during monotherapy
Change in serum lipid parameters (total cholesterol, LDL, HDL, triglycerides) from baseline during CT-01 monotherapy.
Unit of Measure: mmol/L
Measured: Up to 12 months
Change from baseline in Albumin-Bilirubin (ALBI) score during monotherapy
Change from baseline in ALBI score will be evaluated during CT-01 monotherapy. The ALBI score is calculated using serum bilirubin and albumin. Changes from baseline will be summarized by time point. Higher scores indicate worse liver function.
Unit of Measure: score
Measured: Up to 12 months
Change from baseline in Child-Pugh score during monotherapy
Change in Child-Pugh score (range: 5-15; higher scores indicate worse liver function) from baseline during CT-01 monotherapy.
Unit of Measure: score
Measured: Up to 12 months
Change from baseline in MELD-Na score during monotherapy
Change in MELD-Na score (range: typically 6 to 40; higher scores indicate worse liver function) from baseline during CT-01 monotherapy.
Unit of Measure: score
Measured: Up to 12 months
Change from baseline in serum alpha-fetoprotein (AFP) levels during monotherapy
Change in serum AFP concentration from baseline during CT-01 monotherapy. AFP is a tumor marker used in hepatocellular carcinoma.
Unit of Measure: ng/mL
Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 May 20251 Apr 2030

First posted29 May 2025
Study start26 May 2025 (estimated)
Primary completion16 Apr 2029 (estimated)
Study completion1 Apr 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hepatocellular Carcinoma (HCC)Studies 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: Sequential
Masking: None (open label)
Enrolment: 141 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06994572
Sponsor's protocol ID: CT-01-CD-1
Status last verified: May 2025
First submitted: 29 Apr 2025
Last updated: 29 May 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Hepatocellular Carcinoma (HCC) trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label, Dose Escalation, and Dose Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CT-01 as Monotherapy and Combination Therapy With Everolimus in Subjects With Intermediate or Advanced Hepatocellular Carcinoma (BCLC Stage B or C) With Preserved Liver Function (Child-Pugh Class A)
ClinicalTrials.gov ID: NCT06994572
Acronym / sponsor ID: CT-01-CD-1
Conditions: Hepatocellular Carcinoma (HCC)
Phase: Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 141 participants (estimated)
Lead sponsor: Captor Therapeutics S.A.Industry (pharma, biotech, devices)
Study start: 26 May 2025 (estimated)
Primary completion: 16 Apr 2029 (estimated)
Study completion: 1 Apr 2030 (estimated)
First posted: 29 May 2025 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
CT-01 PART 1A: Monotherapy - Dose Escalation	Experimental	Drug: CT-01Subjects receive CT-01 monotherapy at predefined dose levels. Doses assigned according to a dose-escalation protocol.
CT-01 PART 1B: Monotherapy - Dose Expansion	Experimental	Drug: CT-01Subjects receive CT-01 monotherapy at the selected recommended dose level identified in Part 1A
CT-01 PART 2A: Combotherapy - Dose Escalation	Experimental	Drug: CT-01, Drug: EVEROLIMUSSubjects receive CT-01 and everolimus orally once daily in 28-day cycles
CT-01 PART 2B: Combotherapy - Dose Expansion	Experimental	Drug: CT-01, Drug: EVEROLIMUSSubjects receive CT-01 and everolimus at the recommended combination dose.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Able to understand and willing to provide informed consent and able to comply with the study procedures and restrictions.
Are ≥18 years of age and of any gender at the time of screening.
Have confirmed histological and/or radiological diagnosis of HCC with a Child-Pugh Class A score of 5 to 6 points within 7 days of first dose of study drug.
Has BCLC stage B and are ineligible for or are refractory to locoregional therapy and not amenable to a curative treatment approach, or BCLC stage C and are not amenable to a curative treatment approach.
Have progressed on or are intolerant to ≥1 prior systemic standard of care treatment. All available standard of care treatments should have been received as prior systemic treatment if deemed appropriate by the investigator (unless such treatments are deemed contraindicated or inappropriate by the treating physician).

Key exclusion criteria (39 listed)

Have not recovered from toxicities to baseline or Grade ≤1 by CTCAE version 5.0 from prior anticancer therapy, except alopecia and sub-optimally treated nausea, vomiting, or diarrhea.
Have a history of liver transplant.
Any other active malignancy at time of screening or diagnosis of another malignancy within 2 years before screening that requires active treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy.
Have central nervous system (CNS) metastases or any other Grade >2 CNS disorder. Subjects with CNS metastases who are stable on their treatment since a minimum of 4 weeks prior to screening are eligible.
Have recent esophageal or gastric variceal bleeding within 4 weeks prior to screening. Subjects with treated, stable, or small varices without bleeding within the 4 weeks prior to screening are eligible.

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
CT-01Investigational small-molecule degrader targeting transcription factors in HCC. Used as monotherapy or with everolimus in dose-escalation/expansion settings. Specific to protocol CT-01-CD-1.	Drug	CT-01 PART 1A: Monotherapy - Dose Escalation, CT-01 PART 1B: Monotherapy - Dose Expansion, CT-01 PART 2A: Combotherapy - Dose Escalation, CT-01 PART 2B: Combotherapy - Dose Expansion
EVEROLIMUSApproved mTOR inhibitor used in combination with CT-01 for HCC in this study. Evaluated for safety, tolerability, and PK/PD in CT-01-CD-1 protocol.	Drug	CT-01 PART 2A: Combotherapy - Dose Escalation, CT-01 PART 2B: Combotherapy - Dose Expansion

Primary outcome

Number of participants with treatment-emergent adverse events (TEAEs) during CT-01 monotherapy
Time frame: Up to 12 months
Safety and tolerability of CT-01 will be evaluated by monitoring the incidence of TEAEs, SAEs, AESIs, and TEAEs leading to study discontinuation or death. Unit of Measure: Number, nature, sverity and relation plausibility of AE
Maximum tolerated dose (MTDm) of CT-01 monotherapy
Time frame: Up to 12 months
The MTDm will be determined based on the incidence and type of dose-limiting toxicities (DLTs) during Cycle 1 of CT-01 monotherapy. Unit of Measure: mg/day
Number of participants with treatment-emergent adverse events (TEAEs) during CT-01 and everolimus combination therapy
Time frame: Up to 12 months
Safety and tolerability will be assessed through monitoring of TEAEs, SAEs, AESIs, and TEAEs leading to study discontinuation or death during combination therapy. Unit of Measure: Number, nature, sverity and relation plausibility of A
Maximum tolerated dose (MTDc) of CT-01 in combination with everolimus
Time frame: Up to 12 months
The MTDc will be determined based on the incidence of DLTs during Cycle 1 of the combination therapy. Unit of Measure: mg/day

22 secondary outcomes

Objective response rate (ORR) per RECIST v1.1 and mRECIST for CT-01 monotherapy
Time frame: Up to 12 months
Objective response rate (ORR) per RECIST v1.1 and mRECIST for CT-01 and everolimus
Time frame: Up to 12 months
Maximum plasma concentration (Cmax)
Time frame: Up to 12 months
Area under the concentration-time curve (AUC)
Time frame: Up to 12 months
Time to maximum concentration (Tmax)
Time frame: Up to 12 months
Change from baseline in MELD-Na score during combination therapy
Time frame: Up to 12 months
Change from baseline in Child-Pugh score during combination therapy
Time frame: Up to 12 months
Change from baseline in Albumin-Bilirubin (ALBI) score during combination therapy
Time frame: Up to 12 months
Change from baseline in lipid profile during combination therapy
Time frame: Up to 12 months
Change from baseline in serum glucose levels during combination therapy
Time frame: Up to 12 months
Change from baseline in serum alpha-fetoprotein (AFP) levels during combination therapy
Time frame: Up to 12 months
Terminal half-life (T1/2)
Time frame: Up to 12 months
Title: Maximum plasma concentration (Cmax)
Time frame: Up to 12 months
Change from baseline in serum glucose levels during monotherapy
Time frame: Up to 12 months
Area under the concentration-time curve (AUC)
Time frame: Up to 12 months
Time to maximum concentration (Tmax)
Time frame: Up to 12 months
Terminal half-life (T1/2)
Time frame: Up to 12 months
Change from baseline in lipid profile during monotherapy
Time frame: Up to 12 months
Change from baseline in Albumin-Bilirubin (ALBI) score during monotherapy
Time frame: Up to 12 months
Change from baseline in Child-Pugh score during monotherapy
Time frame: Up to 12 months
Change from baseline in MELD-Na score during monotherapy
Time frame: Up to 12 months
Change from baseline in serum alpha-fetoprotein (AFP) levels during monotherapy
Time frame: Up to 12 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CT-01 and EVEROLIMUS in people with Hepatocellular Carcinoma (HCC), run by Captor Therapeutics S.A..

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 15 inclusion and 39 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: opening soon, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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?

Number of participants with treatment-emergent adverse events (TEAEs) during CT-01 monotherapy (time frame: Up to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06994572.

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 29 May 2025.