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First-in-Human Phase I/II Study of FHND-9041 in Patients With EGFR Mutated Advanced Non-Small Cell Lung Cancer

NCT06521034 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2024-07-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

FHND-9041

In Phase I, using a "3+3" design, dose escalation and expansion studies were conducted at doses of 40, 80, 120 and 180 mg/day. At least 3 patients were enrolled in each dose arm, and no dose-limiting toxicities were observed. With a plateau observed at 120 mg/day, the 80 mg/d and 120mg/d groups were selected for dose expansion. The 80mg/d queue has expanded by 36 patients, and the 120mg/d queue has expanded by 39 patients. In Phase Ⅱ, after comprehensive analysis and consultation, at least 30 patients were enrolled according to the inclusion and exclusion criteria. 37 patients with locally advanced or metastatic EGFR-mutated NSCLC receiving first-line treatment were enrolled.

Sponsors & Collaborators

  • Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Yongchang Zhang

    lead OTHER

Principal Investigators

  • Yongchang Zhang · Hunan Cancer Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-27
Primary Completion
2021-05-17
Completion
2021-05-17

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06521034 on ClinicalTrials.gov