Iksuda Therapeutics, a developer of next-generation antibody drug conjugates (ADCs), has unveiled encouraging early data for its HER2-directed ADC, IKS014, in patients with advanced oesophageal cancer.

 

The Phase 1 study, a non-randomised, open-label, multicentre trial, is evaluating IKS014 in patients with locally advanced or metastatic solid tumours expressing HER2. Data shared at the symposium focused on an unplanned sub-population of 10 patients with HER2+ oesophageal cancers treated during the trial’s dose escalation phase in Australia.

 

As of July 2025, 62 patients across five dose levels (40, 60, 90, 120, and 105 mg/m²) had received IKS014, including those with breast, ovarian, gallbladder, lung, and oesophageal cancers. The therapy showed encouraging anti-tumour activity across tumour types and HER2 expression levels.

 

Among the oesophageal cancer cohort, all previously treated (median 3 prior therapies), five patients responded, including one complete response in a patient with non-measurable disease. 

 

Three additional patients maintained stable disease for over six months, yielding a clinical benefit rate of 80%. These results prompted Iksuda to expand the study to include a new cohort of patients with HER2-expressing oesophageal adenocarcinoma who have received at least one prior line of standard therapy, potentially including HER2-directed treatments.

 

Dr Dave Simpson, CEO of Iksuda Therapeutics, said: "The early signs of activity and clinical benefit rate in patients with pretreated advanced oesophageal cancer is extremely encouraging. This is a notoriously difficult cancer to treat, with relatively poor survival rates and high treatment toxicity. 

 

"We look forward to continuing to explore the potential of IKS014 to improve clinical outcomes in this hard-to-treat cancer, as well as across several other HER2-expressing cancers."