China-headquartered Antengene has initiated the combination portion of its ERASER study investigating ATG-017 with nivolumab in patients with advanced solid tumours.

The ERASER study is part of a clinical collaboration between Antengene and Bristol Myers Squibb. The combination part of the study is the first-in-human investigation of ATG-017 – an orally administered selective small molecule ERK1/2 inhibitor – which will take place in Australia and the US. The monotherapy portion of the study is being conducted in parallel just in Australia.

Antengene is using the combination segment of the study to evaluate the safety and tolerability of the candidate. The company has already proven in published preclinical data that an ERK1/2 inhibitor in combination with an immune checkpoint inhibitor (ICI) worked well to improve efficacy in ICI-resistant mice.

The open-label, multi-centre study (NCT04305249) is estimated to enrol 211 participants. The combination with nivolumab, a cycle of study treatment will be defined as 28 days. For the combination group, ATG-017 will be continuously given for 28 days with dose escalation starting at 5mg. Nivolumab will be given at a fixed dosing, 480mg every four weeks on day one of each cycle.

The primary outcome is the assessment of adverse events and serious adverse events, measured after 18 months. Toxicity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE).

Antengene’s chief medical officer Dr Amily Zhang said: “Based on the preclinical data of ATG-017 that showed highly specific selectivity and promising activity, as well as synergistic effects in combination with ICIs, we are confident in ATG-017’s potential as a best-in-class ERK1/2 inhibitor and look forward to continuing to advance this clinical programme of ATG-017.”

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Antengene’s founder, chairman and CEO Dr Jay Mei commented: “Having the first patient dosed in the combination portion of this study of ATG-017 in the US marks another milestone in the development of the drug candidate.”