Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:34 AM
Study NCT ID:
NCT07364357
Status:
RECRUITING
Last Update Posted:
2026-01-23
First Post:
2025-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study of CREPT-618 in Locally Advanced HCC
Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Organization:
Study Overview
Official Title:
An Open-label Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of CREPT-618 in Patients With Locally Advanced Hepatocellular Carcinoma
Status:
RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-center, open-label, dose-escalation Phase I clinical study designed to evaluate the safety (incidence of adverse events), maximum tolerated dose (MTD), optimal biological dose (OBD), and recommended Phase II dose (RP2D) of CREPT-618 in adult patients aged 18-75 with locally advanced hepatocellular carcinoma who have failed standard treatment.
The study adopts a 3+3 dose escalation design for dose climbing, primarily consisting of three dose groups: low dose, medium dose, and high dose. Patient enrollment and dose escalation in each group will be based on safety evaluation results. Pharmacokinetic parameters and preliminary efficacy indicators will also be assessed.
The study adopts a 3+3 dose escalation design for dose climbing, primarily consisting of three dose groups: low dose, medium dose, and high dose. Patient enrollment and dose escalation in each group will be based on safety evaluation results. Pharmacokinetic parameters and preliminary efficacy indicators will also be assessed.
Detailed Description:
This is a single-center, open-label, dose-escalation Phase I clinical study designed to evaluate the safety (incidence of adverse events), maximum tolerated dose (MTD), optimal biological dose (OBD), and recommended Phase II dose (RP2D) of CREPT-618 in adult patients aged 18-75 with locally advanced hepatocellular carcinoma who have failed standard treatment.
The study employs a 3+3 dose escalation design for dose titration, consisting of three primary dose groups: low dose, medium dose, and high dose. Patient enrollment and dose escalation in each cohort will be based on safety evaluation results. Pharmacokinetic parameters and preliminary efficacy indicators will also be assessed.
The study design includes three dose groups, with a total of 7-13 patients. The dose groups are divided into low dose (sentinel dose, 0.5 mg/kg), medium dose (1.5 mg/kg), and high dose (4.5 mg/kg). The low-dose group (sentinel) will enroll 1 patient; the medium-dose group, 3-6 patients; and the high-dose group, 3-6 patients. Each patient will receive single or multiple subcutaneous injections of CREPT-618 administered once every two weeks. Assessment timepoints include safety evaluations, pharmacokinetic (PK) sampling, and efficacy evaluations.
Starting with the sentinel dose, one sentinel patient will be enrolled in the low-dose group and observed for up to 28 days. If no dose-limiting toxicity (DLT) occurs in the sentinel patient, enrollment will proceed to the medium-dose group. Initially, one patient will be enrolled in this group. If no DLT is observed, two additional patients will be enrolled in the medium-dose group. If no DLT occurs in any of these patients, escalation to the high-dose group will begin. If one DLT occurs, one additional patient will be enrolled in the same dose group; if ≥2 DLTs occur, the previous dose will be determined as the MTD.
The high-dose group will enroll three patients, with the possibility of expanding to six if needed. To ensure the trial can escalate to the anticipated effective dose, if no DLTs are observed in the low-, medium-, or high-dose groups, and no changes are observed in objective response rate or liver function indicators, the dose may be adjusted to 9 mg/kg. One patient will be enrolled at this dose level; if no DLT occurs, two additional patients will be enrolled.
If disease progression is observed at the 6-week efficacy assessment, subsequent treatment will involve CREPT-618 administration every two weeks in combination with pembrolizumab. Based on a comprehensive evaluation of safety and pharmacodynamic (PD) data from existing patients, the investigator may adjust the dosing frequency. If higher doses are tolerated and potential benefits are anticipated, dose escalation to a higher dose group is permitted within the same subject (allowed only once).
The study employs a 3+3 dose escalation design for dose titration, consisting of three primary dose groups: low dose, medium dose, and high dose. Patient enrollment and dose escalation in each cohort will be based on safety evaluation results. Pharmacokinetic parameters and preliminary efficacy indicators will also be assessed.
The study design includes three dose groups, with a total of 7-13 patients. The dose groups are divided into low dose (sentinel dose, 0.5 mg/kg), medium dose (1.5 mg/kg), and high dose (4.5 mg/kg). The low-dose group (sentinel) will enroll 1 patient; the medium-dose group, 3-6 patients; and the high-dose group, 3-6 patients. Each patient will receive single or multiple subcutaneous injections of CREPT-618 administered once every two weeks. Assessment timepoints include safety evaluations, pharmacokinetic (PK) sampling, and efficacy evaluations.
Starting with the sentinel dose, one sentinel patient will be enrolled in the low-dose group and observed for up to 28 days. If no dose-limiting toxicity (DLT) occurs in the sentinel patient, enrollment will proceed to the medium-dose group. Initially, one patient will be enrolled in this group. If no DLT is observed, two additional patients will be enrolled in the medium-dose group. If no DLT occurs in any of these patients, escalation to the high-dose group will begin. If one DLT occurs, one additional patient will be enrolled in the same dose group; if ≥2 DLTs occur, the previous dose will be determined as the MTD.
The high-dose group will enroll three patients, with the possibility of expanding to six if needed. To ensure the trial can escalate to the anticipated effective dose, if no DLTs are observed in the low-, medium-, or high-dose groups, and no changes are observed in objective response rate or liver function indicators, the dose may be adjusted to 9 mg/kg. One patient will be enrolled at this dose level; if no DLT occurs, two additional patients will be enrolled.
If disease progression is observed at the 6-week efficacy assessment, subsequent treatment will involve CREPT-618 administration every two weeks in combination with pembrolizumab. Based on a comprehensive evaluation of safety and pharmacodynamic (PD) data from existing patients, the investigator may adjust the dosing frequency. If higher doses are tolerated and potential benefits are anticipated, dose escalation to a higher dose group is permitted within the same subject (allowed only once).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: