Hokkaido phase II study of photo-immunotherapy combination with ASP-1929 for recurrent or persistent EGFR-positive vulvar, vaginal, and cervical cancers not amenable to further radiotherapy (HICARi study)

Background: Photoimmunotherapy using ASP-1929 (ASP1929-PIT) is a novel approach targeting epidermal growth factor receptor (EGFR)-expressing tumors.ASP-1929, an anti-EGFR monoclonal antibody conjugated to IRDye 700DX (IR700), binds to EGFR in tumor cells.Upon exposure to 690-nm red laser light, IR700 is activated, disrupting the cellular membrane.Approved in Japan for head and neck cancer, this therapy is the first of its kind globally.Given its mechanism, ASP-1929 may also treat other EGFR-positive malignancies accessible to red light.Thus, we are conducting a phase II clinical trial of ASP1929-PIT for localized recurrent and persistent vulvar, vaginal, and cervical cancers refractory to radiotherapy (RT).These severely impact quality of life, highlighting an unmet need.Methods: This single-arm, open-label, phase II investigator-initiated trial evaluated the efficacy and safety of ASP1929-PIT for recurrent or persistent vulvar, vaginal, or cervical cancer post-RT (jRCT2011240034).Participants had EGFR expression confirmed by immunohistochemistry, prior RT (including chemoradiotherapy) for the primary lesion,