Trial · NCT06994572
Study of CT-01 as Monotherapy and Combination Therapy in Subjects With Intermediate or Advanced Hepatocellular Carcinoma
NCT06994572, Phase 1, Not yet recruiting, Captor Therapeutics S.A.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of CT-01 as Monotherapy and Combination Therapy in Subjects With Intermediate or Advanced Hepatocellular Carcinoma. Trials, record NCT06994572. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06994572
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of CT-01 as Monotherapy and Combination Therapy in Subjects With Intermediate or Advanced Hepatocellular Carcinoma
- NCT number
- NCT06994572
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 141 participants, estimated
- Lead sponsor
- Captor Therapeutics S.A.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Interventions
- CT-01, EVEROLIMUS
- First posted
- 2025-05-29
- Last updated
- 2025-05-29
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with treatment-emergent adverse events (TEAEs) during CT-01 monotherapy | 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 |
| Primary | Maximum tolerated dose (MTDm) of CT-01 monotherapy | 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 |
| Primary | Number of participants with treatment-emergent adverse events (TEAEs) during CT-01 and everolimus combination therapy | 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 |
| Primary | Maximum tolerated dose (MTDc) of CT-01 in combination with everolimus | 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 |
| Secondary | Objective response rate (ORR) per RECIST v1.1 and mRECIST for CT-01 monotherapy | Up to 12 months | Proportion of participants achieving complete or partial response as per RECIST v1.1 and mRECIST. Unit of Measure: Percentage of participants |
| Secondary | Objective response rate (ORR) per RECIST v1.1 and mRECIST for CT-01 and everolimus | Up to 12 months | Proportion of participants achieving complete or partial response during combination therapy. Unit of Measure: Percentage of participants |
| Secondary | Maximum plasma concentration (Cmax) | Up to 12 months | Cmax will be determined for CT-01 using non-compartmental analysis. Unit of Measure: ng/mL |
| Secondary | Area under the concentration-time curve (AUC) | Up to 12 months | 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 |
| Secondary | Time to maximum concentration (Tmax) | Up to 12 months | Tmax will be recorded as the time to reach Cmax for CT-01. Unit of Measure: Hours |
| Secondary | Change from baseline in MELD-Na score during combination therapy | Up to 12 months | 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 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06994572
GET https://conductscience.org/api/trials/v1/NCT06994572/registered?page=2