The trial will enrol pre-treated patients with advanced HER2-altered NSCLC, including subjects with HER2 exon 20 mutations. Credit: Jo Panuwat D / Shutterstock.

US-based biopharmaceutical company Nuvalent has dosed the first subject in a Phase Ia/IIb trial of NVL-330, a HER2-selective inhibitor designed to treat HER2-altered non-small cell lung cancer (NSCLC).

The multicentre, open-label HEROEX-1 trial will enrol pre-treated patients with advanced HER2-altered NSCLC, including subjects with HER2 exon 20 mutations.

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Its primary aim is to assess NVL-330’s overall safety and tolerability while other trial objectives include assessing the recommended Phase II dose (RP2D) and measuring the drug’s anti-tumour activity.

Nuvalent chief medical officer Christopher Turner said: “HER2 alterations are an important category of oncogenic drivers within NSCLC that includes both HER2 amplification and HER2 mutations, the majority of which are exon 20 mutations.

“At the outset of our programme, physician-scientists outlined the need for a HER2 therapy that maintained activity against HER2 exon 20 mutations, was selective for HER2 versus wild-type EGFR to limit gastrointestinal and skin toxicities associated with EGFR inhibition, and was brain penetrant to address and limit brain metastases.”

NVL-330 is a brain-penetrant HER2-selective tyrosine kinase inhibitor that aims to treat people with HER2-altered tumours, including those with tumours harbouring HER2 exon 20 insertion mutations.

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The drug is designed to alleviate treatment-linked adverse events due to off-target wild-type EGFR inhibition, as well as treat brain metastases.

Nuvalent CEO James Porter said: “The initiation of this trial represents a significant milestone for Nuvalent, marking the third programme from our novel pipeline to enter clinical development in under three years.

“This rapid execution serves as a testament to our team’s dedication to rapid progress and growth across our pipeline, and our unwavering commitment to our goal of bringing precisely targeted therapies to patients with cancer.”

In October 2022, Nuvalent reported positive preliminary data from the Phase I dose-escalation part of the ARROS-1 Phase I/II trial of NVL-520 in advanced ROS1-positive NSCLC and various other solid tumour patients.