drugset / Trial / NCT07364357
A Phase I Study of CREPT-618 in Locally Advanced HCC
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-09-15
- Primary completion
- 2026-08-15
- Completion
- 2027-09-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CREPT-618 | Oligonucleotide (other) | 0.5 mg/kg | Subcutaneous |
| Subject | CREPT-618 | Oligonucleotide (other) | 1.5 mg/kg | Subcutaneous |
| Subject | CREPT-618 | Oligonucleotide (other) | 4.5 mg/kg | Subcutaneous |
| Subject | CREPT-618 | Oligonucleotide (other) | 9 mg/kg | Subcutaneous |