Innovent Biologics Inc. (HKG: 1801) has announced the first subject dosing in a Phase I clinical study for its IBI343, a CLDN18.2 antibody drug conjugate (ADC), in Australia. This marks the first ADC from the Chinese biotech company to enter clinical trials.
Phase I Clinical Study Design
The open-label, multi-center Phase I clinical study is designed to assess the safety, tolerability, and preliminary efficacy of IBI343 in patients with advanced solid tumors. The study aims to determine the maximum tolerated dose (MTD) and/or the recommended Phase II dose (RP2D) of the drug.
Mechanism of Action and Preclinical Results
IBI343 is designed to bind to tumor cells expressing CLDN18.2, a protein frequently overexpressed in certain cancers. Upon binding, the CLDN18.2-dependent ADC is internalized and releases toxin drugs that cause DNA damage, leading to apoptosis of tumor cells. Additionally, free toxin drugs can diffuse through the plasma membrane to kill adjacent tumor cells, demonstrating a bystander effect. Preclinical studies have shown that IBI343 exhibits robust anti-tumor activity in pharmacological models with both low and high expression of CLDN18.2. The drug also demonstrated favorable safety characteristics in preclinical models, with a controllable overall safety profile.-Fineline Info & Tech
