The purpose of this study is to characterize the safety and tolerability of FWD1509 MsOH in
advanced NSCLC patients and establish the maximum tolerable dose (MTD), recommended phase 2
dose (RP2D) in advanced NSCLC patients.
This study will be a first-in-human study evaluating the safety and tolerability of FWD1509
MsOH in subjects with advanced NSCLC, when FWD1509 MsOH is administered once daily as a
single agent. FWD1509 MsOH is an oral TKI (Tyrosine Kinase Inhibitor) that blocks the
function of tyrosine kinase. TKIs such as gefitinib, erlotinib or afatinib are recommended as
the first-line therapy for EGFR mutated (exon 19 deletions or L858R point mutations in exon
21) NSCLC patients. However, the majority (>50%) of patients will develop acquired resistance
after initially responding to gefitinib or erlotinib due to the occurrence of secondary
mutations (mostly T709M) in EGFR. Osimertinib was subsequently developed to such secondary
mutations, but for EGFRex20ins mutations, on which there is still no effective therapies
focusing. FWD1509 MsOH is new generation EGFR-TKI targeting EGFR mutations such as exon 19
deletion, L858R substitution as well as T790M mutations. In particular, FWD1509 MsOH targets
the EGFRex20ins mutation in NSCLC.
The development of FWD1509 MsOH at this stage is mainly focused on treatment of NSCLC tumors
with EGFRex20ins mutations, followed by further exploration against other targets.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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