eligibility_summary
Include: PDAC confirmed, progressed on metastatic FOLFIRINOX (incl NALIRIFOX, maintenance FP progression ok if received all FFX drugs), measurable disease, ECOG 0–1, ≥3‑mo life expectancy, adequate organs/coagulation, ≤G1 neuropathy, contraception/pregnancy test. Exclude: >1 prior metastatic regimen, CNS mets, major comorbidity/infection/recent surgery, bowel obstruction/major GI dz or refractory ascites, prior ICI, ILD, autoimmune/immunosuppression, drug allergy, active HBV/HCV/HIV/TB, pregnancy/breastfeeding, TPN, recent therapy/COVID/vaccine.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Randomized Phase II in metastatic pancreatic ductal adenocarcinoma post‑FOLFIRINOX: nab‑paclitaxel + gemcitabine ± botensilimab (AGEN1181). Botensilimab: fully human, Fc‑enhanced anti‑CTLA‑4 monoclonal antibody (immune checkpoint inhibitor). Mechanism: blocks CTLA‑4 to boost T‑cell priming/activation and, via Fc receptor engagement, can deplete intratumoral regulatory T cells, targets CTLA‑4 pathway on effector T cells and Tregs and engages antigen‑presenting cells. Gemcitabine: antimetabolite nucleoside analog, inhibits DNA synthesis (ribonucleotide reductase inhibition and dFdCTP incorporation), targets proliferating tumor cells. Nab‑paclitaxel: albumin‑bound taxane, stabilizes microtubules and arrests mitosis, targets tumor cell division.