NEW YORK – Iksuda Therapeutics on Monday said it began a Phase I trial of its antibody-drug conjugate IKS014 in patients with advanced HER2-positive solid tumors.
In the trial, researchers will evaluate safety, tolerability, immunogenicity, and anti-tumor activity of the drug in 165 patients with HER2-positive and HER2-low tumors. The HER2-positive cohort will include patients with IHC 2+/ISH+ and IHC 3+ tumors. The HER2-low group will comprise IHC 2+/ISH- and IHC1/ISH-/untested. Patients will receive doses by intravenous infusion on day 1 of each 21-day cycle. The primary outcome measures of the trial are recommended Phase II dose and in the second, dose-expansion part of the trial objective response rate.
The study is currently enrolling patients at five sites in Australia. The Newcastle, UK-based company expects the first data readout from the trial in the second half of 2025.
Iksuda licensed the drug from the Korean biopharma company LegoChem Biosciences, gaining exclusive worldwide rights outside greater China and South Korea to develop and commercialize IKS014, formerly dubbed LCB14. Fosun Pharma is also studying the drug (as FS-1502) in clinical trials in HER2-positive breast cancer patients in China. Fosun has reported positive Phase I data and is progressing it through Phase II and III trials in China.