Innovent Biologics has dosed the first participant in Australia in the Phase I clinical study of IBI343, a recombinant anti-Claudin18.2 monoclonal antibody-drug conjugate (ADC), to treat advanced solid tumour patients.

The multi-centre, open-label Phase I clinical trial has been designed for assessing IBI343’s preliminary efficacy, safety, and tolerability in these patients.

It will also determine the maximum tolerated dose (MTD) and/or the recommended Phase II dose (RP2D).

IBI343 is claimed to be the first ADC drug candidate in the company’s pipeline to enter the clinical trial phase.

It attaches to the Claudin 18.2-expressing tumour cells and then the Claudin 18.2 dependent ADC internalisation occurs, and the drug is released. This will result in DNA damage and eventually the tumour cell apoptosis.

The released drug may also diffuse in the plasma membrane to reach and kill the neighbouring cells, which will result in the ‘bystander killing effect’.

IBI343 showed potent tumour growth inhibition efficacy in Claudin 18.2 high and low expression mice tumour bearing models.

In preclinical in vivo models, the ADC drug candidate demonstrated a tolerable safety profile.

Innovent senior vice-president Dr Hui Zhou said: “At present, target treatment options are limited for gastric and pancreatic cancer where imply huge unmet clinical needs. High expression of Claudin 18.2 in aforesaid tumours suggests its high potential and Innovent has been actively rolling out a cluster of Claudin 18.2 drug candidates across different modalities to seek for differentiated therapeutic values while guarantee druggability.

“In parallel, the IND for IBI343 has been filed in China last month. We are looking forward to the positive results of IBI343 in patients with advanced solid tumours.

“IBI343 is our first ADC molecule to initiate clinical study in both Australia and China, adding a valuable clinical asset in our R&D pipeline that represents Innovent’s global innovation strategy.”

Last month, the company dosed the first participants in the higher-dose cohort of a Phase II clinical trial of mazdutide (IBI362) in adults with obesity in China.