AMPLIFY-201

NCT04853017 📎

Regimen

Experimental
ELI-002 2P: amphiphile-modified mKRAS G12D + G12R long peptides + amphiphile-modified CpG-7909 TLR9 agonist, SC injections on prime-boost schedule
Control
single-arm / no comparator (historical MRD+ post-resection PDAC: near-universal relapse within 6-12 mo)

Population

Post-curative-intent resection + adjuvant therapy for KRAS G12D or G12R mutant PDAC (n=20) or CRC (n=5), with minimal residual disease (MRD) defined by persistent tumor biomarker (CA19-9/CEA) or ctDNA positivity after definitive therapy. Pant Nature Med 2024.

Key finding

First clinical evidence that a lymph node-targeted mKRAS peptide vaccine can elicit robust mKRAS-specific T-cell responses (84% of pts) and correlate with relapse-free and overall survival in MRD+ PDAC/CRC. Safety profile favorable (no grade 3-4 vaccine TRAEs). Led to ongoing randomized phase 2 AMPLIFY-7P (NCT05726864) with expanded 7-peptide formulation covering G12D/G12R/G12V/G12C/G12A/G12S/G13D.

Source: PMID 38195752

Timeline

    Guideline citations

    • NCCN PANCREATIC (p.65)