eligibility_summary
Eligibility: Metastatic/unresectable, relapsed/refractory or intolerant with no standard options. Part A: CRC, NSCLC, HNSCC (non‑nasopharyngeal). Part C: CRC (post FP, oxaliplatin, irinotecan, PD‑1/L1 if dMMR/MSI‑H), NSCLC (post platinum + PD‑1/L1), HNSCC (post platinum + PD‑1/L1), PDAC (post gemcitabine or FOLFIRINOX). ECOG 0–1, measurable disease. Exclude: other malignancy <3y, active CNS mets (treated/stable allowed), recent IV bisphosphonate <4w, VTE <6m. Tissue/biopsy consent.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05983133. Intervention: PF-08046052 (SGN-EGFRd2), an IV, IgG-based bispecific immunotherapy antibody. Mechanism: conditionally agonizes CD28 on T cells only when co-engaged with EGFR on tumor cells, localizing CD28 costimulation to the tumor. Intended effect: boost T‑cell activation, proliferation, cytokine release, and cytotoxicity against EGFR+ cancers while limiting systemic immune activation. Targets/pathways: EGFR on tumor cells (CRC, NSCLC, HNSCC, PDAC) and the T‑cell CD28 co‑stimulatory pathway (TCR/CD28 axis). Study: Phase 1 monotherapy dose escalation/optimization with expansion to evaluate safety and preliminary efficacy in advanced solid tumors.