NCT06641609

A Phase I Study of CFT8919 in Patients With Advanced NSCLC

A Phase I Clinical Study 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).

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 166 (estimated)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase I clinical study designed 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) who carry EGFR mutations. The study includes three parts: dose-escalation, dose-expansion, and cohort-expansion. The primary objectives are to determine the maximum tolerated dose (MTD) in the dose-escalation phase and to assess the antitumor efficacy in the cohort-expansion phase. Secondary objectives include assessing pharmacokinetic parameters, objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). Exploratory objectives will evaluate biomarkers and the relationship between drug exposure and treatment outcomes.

Conditions

• Non-Small Cell Lung Cancer With EGFR Mutation

Interventions

Type	Name	Description
DRUG	Dose-Escalation (Phase Ia) CFT8919 capsule	Phase 1a，enrolled, eligible patients receive CFT8919 150-900mg twice daily.
DRUG	Dose-Expansion (Phase Ib) CFT8919 capsule	Phase 1b，enrolled, eligible patients receive CFT8919 RP2D twice daily.
DRUG	Cohort-Expansion (Phase Ic) CFT8919 capsule	Phase 1c，enrolled, eligible patients receive CFT8919 RP2D twice daily.

Timeline

• Start date: 2024-12-13
• Primary completion: 2025-12-09
• Completion: 2026-04-03
• First posted: 2024-10-15
• Last updated: 2024-10-15

Locations

1 site across 1 country: China