FCN-411 / Fosun Pharma - LARVOL DELTA

A phase I study of FCN-411, a pan-HER inhibitor, in EGFR-mutated advanced NSCLC after progression on EGFR tyrosine kinase inhibitors. (PubMed, Lung Cancer) - P1 | "FCN-411 was well tolerated and demonstrated preliminary antitumor activity in patients with EGFR-mutated NSCLC after progression on EGFR-TKIs, especially in those without EGFR T790M mutation. The RP2D was defined as 8 mg once daily. Future studies are warranted."

Journal • P1 data • Dermatitis • Dermatology • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • ERBB4 • HER-2

A Phase I Study of FCN-411 in Advanced Non-small Cell Lung Cancer Chinese Patients With EGFR Positive Mutation (clinicaltrials.gov) - P1; N=90; Recruiting; Sponsor: Ahon Pharmaceutical Co., Ltd.; N=66 ➔ 90

Clinical • Enrollment change • Monotherapy • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A Phase I Study of FCN-411 in Advanced Non-small Cell Lung Cancer Chinese Patients With EGFR Positive Mutation (clinicaltrials.gov) - P1; N=66; Recruiting; Sponsor: Ahon Pharmaceutical Co., Ltd.; Not yet recruiting ➔ Recruiting; Trial completion date: Dec 2019 ➔ Dec 2021; Trial primary completion date: Jun 2018 ➔ Dec 2020

Clinical • Enrollment open • Monotherapy • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

A validated ultra-performance LC-MS/MS method for quantifying a novel oral EGFR inhibitor FCN-411 in human plasma. (PubMed, Bioanalysis) - "And it was demonstrated to be acceptable according to the guidelines for bioanalytical assay validation. The method was robust, sensitive and repeatable, and it is ready to be applied to measure FCN-411 in a Phase I clinical pharmacokinetic study."

Journal • EGFR

A Phase I Study of FCN-411 in Advanced Non-small Cell Lung Cancer Chinese Patients With EGFR Positive Mutation (clinicaltrials.gov) - P1; N=66; Not yet recruiting; Sponsor: Ahon Pharmaceutical Co., Ltd.

Clinical • Monotherapy • New P1 trial