Iksuda Therapeutics has dosed the first patient in a Phase I trial of antibody drug conjugate (ADC) IKS014 in patients with advanced solid tumours that express HER2.
This follows positive data from Phase I clinical trials through Fosun Pharma, which is now progressing FS-1502 (IKS014) through Phase II and Phase III trials in China.
The study is designed to evaluate the safety and tolerability of increasing dose levels of IKS014 to establish a recommended Phase II dose.
The second, dose-expansion, phase of the study (Phase Ib) is to further evaluate the safety, pharmacokinetics / pharmacodynamics, and efficacy of IKS014 at the recommended Phase II dose. The study is currently enrolling patients at five planned locations in Australia. The Phase Ib trial is expected to read out in the second half of 2025.
Dr Dave Simpson, Chief Executive Officer, Iksuda Therapeutics, said: “The dosing of the first patient in our Phase I trial of IKS014 marks a significant milestone for Iksuda: our transition to being a clinical-stage company. We hope that this trial of IKS014 could lead to improved treatment options for patients with HER2+ solid tumours.”
IKS014 is a human epidermal growth factor receptor 2 (HER2) ADC targeting patients with advanced HER2+ solid tumours. In preclinical trials, it displayed impressive activity in high- and low-HER2 expressing tumours with significantly higher non-severely toxic dose (HNSTD) versus other HER2-directed drugs.
Iksuda gained (exclusive world-wide rights (excluding Greater China and South Korea) to IKS014 from LegoChem Biosciences. Fosun Pharma holds the licence in Greater China where it is designated FS-1502.