AnHeart Therapeutics has dosed the first subject in the Phase II study of its lead candidate taletrectinib in ROS1 fusion-positive lung cancer.

An investigational next-generation tyrosine kinase inhibitor (TKI), taletrectinib is intended to target ROS1 and NTRK fusion mutations for the treatment of TKI-naive or pre-treated patients.

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The multicentre, single-arm, open-label global Phase II study, TRUST-II, will be conducted in non-small cell lung cancer (NSCLC) harbouring with ROS1 fusion gene patients.

It will enrol nearly 119 subjects who will be divided into four groups, depending on their past ROS1 tyrosine kinase inhibitor treatment history.

AnHeart stated that 600mg of taletrectinib will be given to the participants once a day in cycles of 21 days.

Confirmed overall response rate (ORR) is the trial’s primary endpoint.

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AnHeart Therapeutics co-founder and chief medical officer Bing Yan said: “Taletrectinib dosing of the first patient in our global Phase II ROS1 fusion-positive TRUST-II lung cancer trial represents a key milestone for our lead ROS1-directed clinical programme.

“Based on the broad expression of ROS1 fusions across different cancer types, and our recent clinical data presented at ASCO and CSCO showing taletrectinib antitumor activity with a promising safety and efficacy profile, we are proud of advancing this investigational candidate as a potential new therapy for ROS1 fusion-positive lung cancer.”

ROS1 and NTRK rearrangements are expected to be oncogenic drivers in advanced NSCLC patients and other advanced solid tumour patients, respectively.

Taletrectinib provides cancer-fighting treatments to tumour cells selectively while sparing normal cells by targeting ROS1.

AnHeart’s pipeline also includes mIDH1 inhibitor AB-218 and AXL inhibitor AB-329.