eligibility_summary
Eligibility: Adults ≥18 with RECIST-measurable unresectable/metastatic GC/GEJ, BTC, or PDAC, biopsy required (Parts C/D: CLDN18.2 ≥10%, ≥2+), ECOG 0–1, adequate organs. Cohorts combine Spevatamig with SOC chemo (taxanes, gemcitabine±nab-paclitaxel or FOLFIRINOX, FOLFOX/CAPOX) or pembrolizumab across 1L–3L GC/GEJ, 1L PDAC, 2L BTC. Exclude: pregnancy/poor contraception, active autoimmune/immunosuppression, pneumonitis/ILD, untreated/progressing CNS mets, prior CLDN18.2/CD47/SIRPα, cardiac disease, GI obstruction/effusions, VTE <6 mo.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05482893 tests Spevatamig (PT886), a first-in-human bispecific IgG antibody that binds Claudin 18.2 (CLDN18.2) on tumor cells and CD47, localizing CD47 blockade to CLDN18.2+ tumors to disrupt the CD47–SIRPα “don’t‑eat‑me” signal and enhance macrophage phagocytosis/antigen presentation. It’s given alone, with chemotherapy (paclitaxel, gemcitabine ± nab-paclitaxel, mFOLFOX6/CAPOX, gemcitabine+FOLFIRINOX), or with pembrolizumab (anti‑PD‑1). Targets/pathways: CLDN18.2+ gastric/GEJ, PDAC, and BTC tumor cells, myeloid checkpoint CD47–SIRPα, T‑cell PD‑1 checkpoint, cytotoxic chemo pathways (microtubules, nucleoside antimetabolites, platinum DNA crosslinking, thymidylate synthase inhibition). Parts C/D require ≥10% (≥2+) CLDN18.2 expression.