eligibility_summary
Eligibility: Adults 18–75 with histologically confirmed HPV-associated (HPV/p16+) cancer (measurable or not), after ≥1 NCCN-standard therapy ≥28 days prior, ECOG 0–1, toxicities ≤ grade 1, adequate organ function, able to attend visits, effective contraception. Exclude: serious uncontrolled or pulmonary disease, active hepatitis or HBV/HCV+, chronic systemic steroids, interacting meds, recent/ongoing investigational trials, noncompliance, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: IBRX-042 (hAd5-HPV E6.ETSD-IRES-E7.ETSD), a viral vector therapeutic cancer vaccine (adenoviral serotype 5) delivered by injection. Mechanism: delivers HPV E6 and E7 antigens engineered with an endosomal/lysosomal targeting domain (ETSD) to enhance antigen processing and presentation on MHC I and II, driving a Th1-biased immune response and robust HPV-specific CD8+ cytotoxic and CD4+ helper T cells to kill HPV-expressing tumor cells. Targets: dendritic cells/antigen-presenting cells, MHC I/II presentation pathways, TCR-mediated activation of CD8+/CD4+ T cells, and tumor cells expressing HPV E6/E7 (often p16+).