IDEAYA Biosciences announces IND clearance for IDE034, a potential first-in-class bispecific B7H3/PTK7 TOP1 ADC targeting multiple solid tumor types

CAR-T Digest - August 2020

Weekly Digest - December 2025

01 December 2025: IDEAYA Biosciences announces IND clearance for IDE034, a potential first-in-class bispecific B7H3/PTK7 TOP1 ADC targeting multiple solid tumor types

IDEAYA has received FDA IND clearance for IDE034, a potential first-in-class bispecific B7H3/PTK7 TOP1 ADC, paving the way for a Phase 1 clinical trial to begin in Q1 2026 for solid tumors that co-express both targets
The clearance follows compelling preclinical data, where IDE034 monotherapy induced deep and durable tumor regressions across multiple in-vivo models positive for B7H3 and PTK7, highlighting its strong therapeutic promise
This dual-targeted approach is particularly significant given that B7H3/PTK7 co-expression is observed across several major cancers including approximately 30% of lung, 46% of colorectal, and 27% of head and neck tumors, supporting broad potential clinical applicability
IDEAYA also reported that combining IDE034 with its PARG inhibitor, IDE161, further enhanced response durability in preclinical studies, with more detailed mechanistic insights expected to be presented in H1 2026
With IDE034, the company expands its growing portfolio of first-in-class TOP1 ADC programs, reinforcing its strategy to improve TOP1 ADC response durability through synergistic DNA damage response (DDR)–based combination approaches