Antengene’s ATG-022 Advances to Dose Expansion Phase in Phase II CLINCH Study for Solid Tumors

Antengene Corporation Ltd (HKG: 6996), a leading biopharmaceutical company based in China, has announced that ATG-022, an antibody drug conjugate (ADC) targeting Claudin 18.2 (CLDN18.2), has progressed into the dosage expansion phase of the Phase II CLINCH study. This trial is evaluating ATG-022 as a monotherapy for advanced or metastatic solid tumors in both China and Australia. Preliminary clinical data from the ongoing CLINCH study has shown promising results, with patients achieving both partial remission (PR) and complete remission (CR).

The CLINCH study is a multicenter, open-label Phase I/II trial designed to assess the safety, tolerability, and maximum tolerated dose of ATG-022, ultimately establishing the recommended Phase II dosage (RP2D). The current dose expansion phase aims to enroll patients with gastric cancer and various other solid tumor types.

Claudins, which are cell adhesion molecules, typically function within tight junctions to regulate cell permeability. In cancer, these molecules are aberrantly expressed on the cell surface, with the CLDN18.2 isoform being notably overexpressed in primary malignant tumors such as gastric, esophageal, and pancreatic cancers. Notably, ATG-022 received Orphan Drug Designation (ODD) in the US for the treatment of pancreatic and gastric cancers in May 2023.- Flcube.com

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