eligibility_summary
Inclusion: HNSCC (non-nasopharyngeal/cutaneous), recurrent, 1st-line pembrolizumab+/-chemo eligible, no distant mets, >=1 PIT-accessible RECIST lesion, PD-1/PD-L1 naive, CPS >=1, HPV status, ECOG 0-1, adequate organs, contraception. Exclusion: recent/active other cancers, severe cetuximab reaction, transplant, CNS mets, <3 mo survival, active autoimmune, ILD/pneumonitis, infections (TB/HBV/HCV/HIV), recent bleeding, uncontrolled illness, recent therapies, ASP-1929, steroids >10 mg, live vaccine, light-exposure needs, recent/planned major surgery.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 3, first-line locoregional recurrent HNSCC. Interventions: 1) ASP-1929 photoimmunotherapy (cetuximab sarotalocan, antibody–photoabsorber conjugate) + pembrolizumab. ASP-1929 binds EGFR on tumor cells, 24±4 h later 690 nm light (PIT690 Laser System) activates the IR700 dye to induce rapid, selective membrane damage and immunogenic cell death with antigen/DAMP release (photoimmunotherapy). 2) Control: pembrolizumab alone or with chemotherapy (cisplatin/carboplatin: platinum DNA crosslinkers, 5-fluorouracil: antimetabolite inhibiting thymidylate synthase, paclitaxel/docetaxel: taxane microtubule stabilizers). Cells/pathways targeted: EGFR-expressing HNSCC cells (ASP-1929), PD-1 checkpoint on T cells (pembrolizumab) to restore antitumor immunity, plus DNA synthesis/repair and mitosis pathways (chemo). Combination aims to kill EGFR+ tumors and enhance T-cell priming/infiltration.