Phase 1b/2 ANO31905 CLDN18.2×CD3 bispecific + chemo in first-line PDAC

This open-label, nonrandomized Phase 1b/2 study (n=84) tests two dose levels of ANO31905 plus gemcitabine and nab-paclitaxel in untreated CLDN18.2-positive locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma, with dose-limiting toxicity guiding Phase 1b and ORR as the Phase 2 primary efficacy endpoint. ANO31905, also known as QLS31905, is a Qilu Pharmaceutical-originated bispecific T-cell engager that binds CLDN18.2 on tumor cells and CD3 on T cells to redirect T-cell killing; Anova Innovation sponsors this U.S. study. Gemcitabine is a nucleoside analog that disrupts DNA synthesis, while nab-paclitaxel is an albumin-bound taxane that stabilizes microtubules and blocks mitosis. CLDN18.2 is found in roughly half of PDAC by broad IHC definitions, although stringent trial-like thresholds may identify closer to one-quarter; today’s first-line options include NALIRIFOX/FOLFIRINOX or gemcitabine/nab-paclitaxel, and this asks whether adding targeted T-cell engagement can improve the familiar gem/nab-pac backbone. This is not first-in-human: the same molecule already has broader clinical development, including a separate Phase 3 first-line PDAC program.