Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521034
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
First-in-Human Phase III Study of FHND-9041 in Patients With EGFR Mutated Advanced Non-Small Cell Lung Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Omprehensive First-in-Human Phase III Study of FHND-9041 in Patients With EGFR Mutated Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2024-07
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:
Helpful
Brief Summary:
FHND-9041 capsule is a novel third-generation EGFR inhibitor targeting EGFR-sensitive mutations This first-in-human study is a single-arm multi-center open-label non-randomized Phase ⅠII trial It aims to evaluate the tolerability safety pharmacokinetics and anti-tumor activity of FHND-9041 in patients with NSCLC harboring the EGFRT790M mutation particularly those acquiring resistance to prior EGFR-TKI treatment Additionally the study seeks to determine the Recommended Phase II Dose RP2D of FHND-9041and assess its efficacy as a first-line treatment for patients with locally advanced or metastatic NSCLC harboring EGFR-sensitive mutations
Detailed Description:
FHND-9041 capsule is a novel third-generation EGFR inhibitor targeting EGFR-sensitive mutations This first-in-human study is a single-arm multi-center open-label non-randomized Phase ⅠII trial It aims to evaluate the tolerability safety pharmacokinetics and anti-tumor activity of FHND-9041 in patients with NSCLC harboring the EGFRT790M mutation particularly those acquiring resistance to prior EGFR-TKI treatment Additionally the study seeks to determine the Recommended Phase II Dose RP2D of FHND-9041and assess its efficacy as a first-line treatment for patients with locally advanced or metastatic NSCLC harboring EGFR-sensitive mutations The primary end point was Pharmacokinetic Parameters and secondary endpoints was ORR and PFS etc
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