Yuhan Corporation is accelerating clinical development of YH42946, an oral HER2-targeting cancer drug, aiming to secure early Phase 1 results by the end of this year and begin a Phase 2 trial early next year.
The company said on the 14th that it disclosed the design and current status of the Phase 1/2 trial of YH42946 at the 2026 World Conference on Lung Cancer (WCLC) held at COEX in Seoul.
YH42946 is an oral targeted therapy aimed at HER2, a protein that drives cancer cell growth. Yuhan has been developing the drug since licensing the technology from J INTS BIO in 2023. Its target patient population covers not only HER2 mutations, amplification and overexpression but also cancers carrying EGFR exon 20 insertion mutations.
The drug's potential against brain metastases is drawing particular attention. Patients with HER2 or EGFR exon 20 mutations frequently develop brain metastases, but some existing treatments require intravenous administration or carry limitations such as toxicity. YH42946 is being developed as an oral drug, and animal studies confirmed its effect on tumors that had spread to the brain.
The ongoing Phase 1/2 trial enrolls patients with advanced or metastatic solid tumors carrying HER2 or EGFR exon 20 mutations. The Phase 1 portion escalates doses in stages to assess safety, the appropriate dose and early anti-tumor activity.
Yuhan expects to obtain Phase 1 results on safety and early anti-tumor activity by the end of this year. Based on those findings, the company plans to select two dose levels and begin a Phase 2 trial in early 2027 to determine the optimal dose. It then intends to expand development to other types of solid tumors with HER2 abnormalities.
"YH42946 is a new treatment option for patients with solid tumors carrying HER2 abnormalities and EGFR exon 20 insertion mutations — an oral drug that can also be expected to show effect on brain metastatic lesions," said Kim Yeul-hong, president and head of R&D at Yuhan. "We will move quickly to establish the recommended dose and advance follow-up development."
