eligibility_summary
Eligible: histologic/cytologic locally advanced, unresectable and/or metastatic cancer with measurable disease (RECIST 1.1), KRAS G12D mutation (tumor or ctDNA), ECOG 0–1, ≥1 prior systemic chemo, asymptomatic/treated CNS disease allowed. Exclude: active CNS mets or carcinomatous meningitis, unresolved >Grade 1 toxicities, significant cardiac disease, uncontrolled infection, active HBV/HCV, other active malignancy unless in remission with >2-year expectancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
MOONRAY-01 (NCT06586515) tests LY3962673, an investigational oral small-molecule targeting KRAS G12D, as monotherapy or with standard chemotherapies in KRAS G12D–mutant solid tumors (PDAC, NSCLC, CRC). Mechanisms: LY3962673—direct KRAS G12D inhibition to suppress oncogenic RAS signaling, cetuximab—anti-EGFR IgG1 mAb blocking upstream receptor signaling, gemcitabine—antimetabolite nucleoside analog inhibiting DNA synthesis, nab-paclitaxel—microtubule stabilizer, oxaliplatin—DNA crosslinking platinum, irinotecan—topoisomerase I inhibitor, 5-FU—thymidylate synthase inhibitor, potentiated by leucovorin (folinic acid). Targets/pathways: KRAS G12D–mutant tumor cells, EGFR→RAS→RAF→MEK→ERK (MAPK) and PI3K–AKT pathways, DNA replication/repair and mitotic spindle in proliferating cancer cells.