eligibility_summary
Eligible: locally advanced/metastatic malignancy with KRAS G12D confirmed by CLIA-certified NGS/PCR. Part 1: advanced solid tumors with ≥1 prior systemic therapy. Disease must be measurable per RECIST v1.1 (Part 1: evaluable/measurable, Parts 2–3: measurable). Exclude: active brain mets or carcinomatous meningitis, significant cardiovascular disease, active IV-treated infection, prior KRAS inhibitor. Other criteria may apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06428500 tests QTX3046 ± cetuximab in advanced solid tumors with KRAS G12D. QTX3046: oral small‑molecule, allele‑selective KRAS G12D inhibitor designed to block active KRAS-driven signaling, suppressing downstream RAF–MEK–ERK (MAPK) and PI3K–AKT pathways in KRAS G12D–mutant tumor cells. Cetuximab: intravenous anti‑EGFR IgG1 monoclonal antibody that blocks ligand‑dependent EGFR activation, reduces downstream RAS/MAPK signaling, and can induce ADCC. Targets/cells/pathways: KRAS G12D–mutant cancer cells, EGFR‑expressing tumor cells, key nodes in the RAS/MAPK and PI3K/AKT pathways. The combination aims to prevent EGFR‑mediated feedback reactivation of RAS signaling.