First-in-Human Phase I/II Study of FHND-9041 in Patients With EGFR Mutated Advanced Non-Small Cell Lung Cancer
NCT Number: NCT06521034
Acronym: Helpful
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Non-small Cell Lung Cancer|EGFR Gene Mutation|EGFR-TKI Sensitizing Mutation
Interventions: DRUG: FHND-9041
Sponsor: Yongchang Zhang
Collaborators: Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 124
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-06-27
Completion Date: 2021-05-17
Locations: Yongchang Zhang, Changsha, Hunan, 410000, China

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 Ⅰ/II 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.

Primary Outcome Measures: Pharmacokinetic Parameters of Maximum Serum Concentration (Cmax) after cycle 1, Maximum serum concentration (Cmax) in patients with locally advanced or metastatic EGFR T790M mutation non-small cell lung cancer (NSCLC) who treated with FHND-9041., through study completion, an average of 1 year|Pharmacokinetic Parameters Area Under the Concentration-Time Curve After Cycle 1, Area under the concentration versus-time curve from time 0 to the last quantifiable concentration (AUClast) and during the dosing interval (AUCtau) of FHND-9041 was assessed., through study completion, an average of 1 year
Secondary Outcome Measures: Objective Response Rate, Objective response rate (ORR) was defined as unconfirmed complete response (CR) and partial response (PR) as assessed by the investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions., Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 12 months post-dose|Treatment-Emergent Adverse Events of Any Grade by System Organ Classes, Adverse events (AEs) were to be coded using MedDRA Version 20.1 and assigned severity grades based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after initiating the study drug after last dose of study drug., Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to approximately 12 months post-dose|Progression free survival, Progression-free survival (PFS) is defined as the time from random assignment to disease progression or death from any cause., Time from first subject dose to study completion, or up to 36 month