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Article source: Medical Rubik's Cube Info
Author: Sunshine
On November 23, the CDE official website showed that Turning Point's TPX-0022 capsule clinical trial application was approved by the Food and Drug Administration for the treatment of locally advanced or metastatic non-small cell lung cancer, gastric cancer or solid tumors with MET gene mutations
TPX-0022 is an oral multi-target kinase inhibitor targeting MET and related cancer signaling pathways SRC and CSF1R
MET is a tyrosine kinase receptor for hepatocyte growth factor (HGF).
TPX-0022 (elzovantinib) has a new three-dimensional macrocyclic structure that can inhibit MET, CSF1R (colony stimulating factor 1 receptor) and SRC kinase, and has the potential to regulate the tumor microenvironment to enhance its therapeutic effect
In October 2021, Turning Point announced the latest clinical data for the dose exploration part of the Phase I SHIELD-1 study
In response to feedback from the FDA, Turning Point plans to initiate the phase II part of the SHIELD-1 study, and at the same time to initiate the phase Ib/II SHIELD-2 study in combination with epidermal growth factor receptor (EGFR) targeted therapy in mid-2022 (see The new drug clinical research application (IND) will be approved by the FDA depending on the time)