Iksuda Therapeutics receives FDA IND clearance for IKS014

CAR-T Digest - August 2020

01 July 2025: Iksuda Therapeutics receives FDA IND clearance for IKS014

The U.S. FDA has cleared Iksuda Therapeutics’ IND application for IKS014, a HER2-targeting ADC, enabling expansion of its ongoing Phase 1 clinical trial
IKS014 is being evaluated in an open-label Phase 1 dose-escalation study for safety, tolerability, and to determine the recommended Phase 2 dose
The trials expansion Phase will include HER2+ breast cancer patients refractory to Enhertu, HER2-low breast cancer patients, and HER2+ gastric cancer patients
With IND clearance, Iksuda will now include U.S. sites in its trial alongside Australia, New Zealand, and Singapore, with Phase 1 expected to complete in 2H 2026