IDEAYA receives FDA approval to begin IDE034 clinical trial

IDEAYA has received the US Food and Drug Administration (FDA) clearance of an investigational new drug (IND) application to begin a Phase I clinical trial of IDE034 for multiple solid tumour types.

IDE034 is a bispecific B7 homolog 3 / protein tyrosine kinase 7 topoisomerase 1 (B7H3/PTK7 TOP1) antibody-drug conjugate (ADC).

The trial will initially assess patients with solid tumours expressing B7H3 and PTK7, including colorectal, lung, ovarian/gynaecological, and head and neck cancers, with enrolment scheduled to start in the first quarter of 2026.

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Preclinical data indicate that IDE034 delivered strong anti-tumour activity and durable regressions as monotherapy in B7H3/PTK7-positive models.

IDEAYA president and CEO Yujiro Hata said: “We are excited to advance our differentiated clinical strategy with now three potentially first-in-class clinical-stage programmes focused on enhancing the efficacy of TOP1 ADCs through the PARG DNA damage response (DDR) combination mechanism.

“We believe this approach addresses a key unmet need by improving the durability of response to TOP1 payload-based ADC therapies. We are targeting to share additional preclinical data to support the PARG and TOP1 ADC combination rationale at a major medical conference in H1 2026.”

IDEAYA chief medical officer Darrin Beaupre said: “IND clearance for IDE034 is an important step in expanding our potential first-in-class TOP1 ADC clinical pipeline into bispecific, precision-guided approaches.

“IDE034 has demonstrated robust antitumour activity and selective targeting of B7H3- and PTK7-expressing solid tumour models. The high prevalence of B7H3/PTK7 co-expression in solid tumours such as lung, colorectal, and head and neck cancers underscores its broad indication potential.”

In July 2024, IDEAYA Biosciences reported positive interim data from a Phase II trial of IDE397 to treat methylthioadenosine phosphorylase (MTAP) deletion urothelial and non-small cell lung cancer (NSCLC).

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