The clinical trial, designated AK138D1-201, aims to validate the company’s IO2.0 + ADC2.0 strategy. HER3 expression is a known driver of tumor progression and therapeutic resistance, yet previous efforts to target the protein have been hindered by toxicity concerns. Akeso designed AK138D1 to minimize uptake in healthy tissue and improve deep tumor penetration, a structural approach intended to bypass the traditional binding site barrier.
In section Releases
Akeso Initiates Phase Ib/II Trial for HER3 ADC in Lung Cancer Patients
Akeso has dosed the first patient in a Phase Ib/II clinical study evaluating AK138D1, its next-generation HER3 antibody-drug conjugate. The trial investigates the drug as both a monotherapy and in combination with ivonescimab, targeting advanced non-small cell lung cancer across multiple treatment resistance scenarios.
Early data from studies in China and Australia indicate that the candidate possesses potent anti-tumor activity without the interstitial lung disease associated with other agents in the class. By pairing this ADC with ivonescimab—a PD-1/VEGF bispecific antibody—researchers hope to leverage synergistic immune-activating effects. This combination is currently being tested in patients who have failed EGFR-TKI therapies or immuno-chemotherapy, representing a significant shift in how the company approaches refractory lung cancer cases. Akeso continues to advance its broader pipeline, with several other bispecific and multispecific candidates currently moving through mid-stage clinical development.
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