ADC Programs


HER2-directed ADC for HER2+ solid tumors

IKS014 is currently in Phase 1 clinical trials in Australia for the treatment of patients with advanced HER2+ solid tumors.

Note: Patients are being recruited for Phase 2 trials in China (as FS-1502) for use in HER2+ solid tumors, and for a Phase 3 trial in China (as FS-1502) for the treatment of HER2+ advanced or metastatic breast cancer vs Kadcyla.

IKS014 development status

Breast, Gastric, Lung
Research Pre-clinical Clinical

Clinical trial overview

NCT05872295 is an open label, uncontrolled non-randomized multi-center, 2 part study assessing IKS014 in patients with HER2+ solid tumors that is either relapsed, refractory to, or intolerant of existing therapy/ies, or for which no standard of care is available.

Part I is a dose escalation 3+3 design study, with a primary objective of safety (MTD).

Part II is a dose expansion study in specified indications, with a primary objective of Objective Response Rate (ORR)

HER2 expression is defined as IHC3+, IHC2+/FISH+ or FISH+ and HER2-low expression is defined as IHC1+ or IHC2+/FISH-

Patients are currently being recruited for sites in Australia

Site locations


Australia Linear Clinical Research, 1 Hospital Avenue, B-Block, 1st Floor, Nedlands WA 6009, Australia

Peninsula & South Eastern Haematology and Oncology Group (PSEHOG), South Building, 5 Susono Way, Frankston VIC 3199        

Frankston Hospital, 2 Hastings Rd, Frankston VIC 3199, Australia

Concord Repatriation General Hospital, Hospital Rd, Concord NSW 2139

Westmead Breast Cancer Institute, Block F/189 Cnr Hawkesbury & Darcy Rd, Westmead NSW 2145

Differentiation by design

IKS014 is comprised of an anti-HER2 antibody, engineered for site-specific of MMAF payload.

A beta-glucuronide liker is used for tumor selective enzymatic payload release. 

Tumor-selective payload activation drives a differentiated clinical profile

Phase 1 clinical studies of FS-1502 in HER2+ advanced breast cancer have confirmed an improved safety profile compared with other HER2-directed ADCs.

Compared with Enhertu and Kadcyla, there is significantly less neutropenia and thrombocytopenia and, importantly, a lack of dose-limiting ILD or respiratory disorders. ALso, unlike Blenrep - the only MMAF based ADC on market - FS-1502 is not associated with dose-limiting corneal toxicity or loss of visual acuity.

This enhanced safety profile does not come at the expense of efficacy - at the median follow-up of 5.2 months, FS-1502 showed a similar ORR in this patient population at a similar data cut-off point.    

Iksuda has Best in class TI for HER2-directed therapies

Preclinical data has shown that IKS014 is associated with a significantly superior TI over Kadcyla and Enhertu.

Efficacy was similar or better than Enhertu and superior to Kadcyla in xenograft models for breast and gastric with moderate-to-high HER2 expression, whilst GLP toxicology confirmed a differentiated toxicity profile and an HNSTD of >12-fold the minimal effective dose (MED).

Preclinically, the advanced ADC design of IKS014 was shown to avoid dose-limiting ocular toxicities that are associated with MMAF-based ADCs, and respiratory, blood & lymphatic toxicities that are dose-limiting for other anti-HER2 ADCs including Enhertu.

Company Genetech/ Roche Daiichi Sankyo/ AstraZeneca Mersana/ Takeda Iksuda
Payload (DAR)


Auristatin D
MED (JIMT-1) >20mg/kg >10mg/kg 1mg/kg 1mg/kg
HNSTD 30mg/kg 30mg/kg 2.5mg/kg 12mg/kg
TI <1.5 <3 2.5 12