drugset / Trial / NCT06641609
A Phase I Study of CFT8919 in Patients With Advanced NSCLC
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of CFT8919 capsules in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying EGFR mutations. The main questions it aims to answer are: * What is the maximum tolerated dose (MTD) of CFT8919? * Does CFT8919 demonstrate antitumor activity in these patients? Participants will: * Take CFT8919 capsules at different doses. * Undergo regular assessments for safety, pharmacokinetics, and tumor response. Researchers will compare different dose levels to determine the best balance between safety and efficacy.
Timeline
- Start
- 2024-12-13
- Primary completion
- 2025-12-09
- Completion
- 2026-04-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CFT8919 | Unknown | 150 mg | Oral |
| Subject | CFT8919 | Unknown | 300 mg | Oral |
| Subject | CFT8919 | Unknown | 600 mg | Oral |
| Subject | CFT8919 | Unknown | 900 mg | Oral |