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

NCT06994572 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2025-05-29

No results posted yet for this study

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).

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

DRUG

CT-01

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.

DRUG

EVEROLIMUS

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.

Sponsors & Collaborators

  • Captor Therapeutics S.A.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-26
Primary Completion
2029-04-16
Completion
2030-04-01

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06994572 on ClinicalTrials.gov