Study is designed to evaluate the safety and tolerability of increasing dose levels of the antibody drug conjugate, IKS014, to establish a recommended Phase 2 dose 

IKS014 is the first of Iksuda’s ADCs to enter clinical trials 

Newcastle, UK, 23 October 2023: Iksuda Therapeutics (Iksuda), the developer of class leading antibody drug conjugates (ADCs) with enhanced tumour specificity, today announces that the first patient has completed a first cycle of therapy with IKS014, a human epidermal growth factor receptor 2 (HER2) ADC targeting patients with advanced HER2+ solid tumours. This follows positive data from Phase 1 clinical trials through Fosun Pharma, which is now progressing FS-1502 (IKS014) through Phase 2 and Phase 3 trials in China. 

The open-label, interventional study (https://clinicaltrials.gov/study/NCT05872295) is designed to evaluate the safety and tolerability of increasing dose levels of IKS014 to establish a recommended Phase 2 dose. The second, dose-expansion, phase of the study (Phase 1b) is to further evaluate the safety, pharmacokinetics / pharmacodynamics, and efficacy of IKS014 at the recommended Phase 2 dose. The study is currently enrolling patients at five planned locations in Australia. The Phase 1b trial is expected to read out in 2H 2025. 

Dr Dave Simpson, Chief Executive Officer, Iksuda Therapeutics, said:  
“The dosing of the first patient in our Phase 1 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.”