Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641609
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
A Phase I Study of CFT8919 in Patients With Advanced NSCLC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None