Antengene's ATG-022 Phase I CLINCH Trial for Solid Tumor Treatment Receives IND Approval in China

14 March 2023 | Tuesday | News

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative commercial stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced that the China National Medical Products Administration (NMPA) has approved the Phase I study of ATG-022 for the treatment of advanced or metastatic solid tumors (the CLINCH Trial).
Image Source : Public Domain

Image Source : Public Domain

-  Discovered and developed in-house by Antengene's R&D team, ATG-022 is an antibody-drug-conjugate (ADC) targeting the Tumor Associated Antigen (TAA) Claudin 18.2.
-  The Phase I CLINCH trial is designed to evaluate the safety, pharmacology, and preliminary efficacy of ATG-022 monotherapy in patients with advanced or metastatic solid tumors. ATG-022 has also received the clinical trial clearance (CTN) by the Bellberry Human Research Ethics Committee (HREC) in Australia and is currently recruiting patients with advanced or metastatic solid tumors.

The CLINCH trial is a multi-center, open-label Phase I dose-finding study of ATG-022 monotherapy in patients with advanced or metastatic solid tumors. The primary objective of the study is to evaluate the safety and tolerability of ATG-022 and to determine important dosing parameters including maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of ATG-022 monotherapy. The secondary objective is to characterize the pharmacology and evaluate the preliminary efficacy of ATG-022.

"Developed in-house by Antengene, ATG-022 is a potential best-in-class ADC that can target Claudin 18.2 with high affinity and recently published industry results have validated Claudin 18.2 as an important cancer target," said Dr. Bo Shan, Antengene's Chief Scientific Officer. "We believe that this IND clearance in China is an important milestone for ATG-022 because of the agent's potential role in the treatment of gastric cancer and other advanced solid tumors. We look forward to initiating patient enrolment for this study and beginning to work with our investigators to evaluate the therapeutic utility this drug as soon as possible."


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