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)
Light-activated immunotherapy expands to treat gynecologic cancers with limited options, offering hope for patients who can't receive radiation.
The HICARi Phase II trial is the first to evaluate ASP-1929 near-infrared photo-immunotherapy (the only globally approved photo-immunotherapy agent, previously limited to head and neck cancer in Japan) in recurrent/persistent EGFR-positive vulvar, vaginal, and cervical cancers that cannot receive further radiotherapy. This addresses a significant unmet need as these patients have very limited treatment options and poor quality of life, with the mechanism targeting EGFR-expressing tumor cells via light-activated membrane disruption.
What the study was
- Study design
- Phase II single-arm open-label investigator-initiated trial
- Population
- EGFR-positive recurrent/persistent vulvar, vaginal, or cervical cancer patients not amenable to further radiotherapy
- Sample size
- 16
- Category
- Treatment Innovation
- Maturity
- Exploratory
- Journal
- Journal of Gynecologic Oncology
Why it surfaced
First photo-immunotherapy clinical trial in gynecologic cancers — an entirely novel mechanism for RT-refractory disease. ASP-1929 is the only approved photo-immunotherapy worldwide. Small trial (n=16) but addresses major unmet need; elevated to HIGH by NOVEL_TREATMENT flag. J Gynecol Oncol.
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