IDEAYA Biosciences announced that it has enrolled its first patient in a Phase 1 combination study of its DLL3‑targeting antibody‑drug conjugate (ADC) IDE849 and its poly(ADP‑ribose) glycohydrolase (PARG) inhibitor IDE161. The study, registered under NCT07174583, will evaluate safety, tolerability, and preliminary efficacy in patients with DLL3‑upregulated solid tumors, including small cell lung cancer, neuroendocrine tumors, neuroendocrine carcinomas, and melanoma.
The trial will be conducted at multiple global sites across North America, Europe, Australia, South America, and Asia. IDE849 is a first‑in‑class TOP1‑payload ADC that delivers a topoisomerase‑I poison directly to DLL3‑expressing cells, while IDE161 is a novel PARG inhibitor designed to block DNA repair and sustain TOP1 lesions. The combination is intended to increase tumor cell killing by preventing the repair of DNA damage induced by the ADC, a strategy supported by preclinical synergy data.
CEO Yujiro S. Hata said the enrollment “is a key step toward launching a registrational study by year‑end, and the advancement of our wholly owned first‑in‑class clinical combination of IDE849 and IDE161 in DLL3‑upregulated solid tumor indications.” Dr. Darrin M. Beaupre added, “We are leveraging our deep scientific expertise in DNA damage repair to enable this rational combination with IDE161, with the goal of inducing accumulation of TOP1 lesions to enhance the clinical efficacy and durability of our proprietary TOP1‑payload ADCs, including IDE849 and IDE034, a Phase 1 B7H3/PTK7 bispecific TOP1 ADC.”
This first clinical milestone for the IDE849/IDE161 partnership expands IDEAYA’s DLL3‑targeted pipeline into a broader patient population and aligns with the company’s strategy of pairing platform ADCs with complementary mechanisms of action. Successful enrollment positions IDEAYA to progress toward a registrational trial and potentially broaden its market reach in aggressive solid tumors.
The study’s focus on DLL3‑upregulated cancers—small cell lung cancer, neuroendocrine tumors, neuroendocrine carcinomas, and melanoma—highlights IDEAYA’s precision‑medicine approach. By combining a TOP1‑payload ADC with a PARG inhibitor, the company aims to create a first‑in‑class therapeutic that could improve outcomes for patients with limited treatment options.
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