RMC-6236-001

NCT05379985 📎

Regimen

Experimental
Daraxonrasib (RMC-6236) 300 mg PO QD continuous dosing
Control
single-arm / no comparator (historical 2L PDAC SoC benchmark mOS 5-7 mo with 5FU/nal-IRI or FOLFOX)

Population

Previously treated locally advanced/metastatic solid tumors with KRAS G12X mutation (G12D/G12V/G12C/G12R/G12A/G12S); PDAC monotherapy cohort n=127 at 300 mg QD; second-line PDAC KRAS G12X subgroup n=22 in updated analysis presented at ESMO 2023/ASCO GI 2024-2025. Global sites.

Key finding

First-in-class pan-KRAS G12X RAS(ON) multi-selective tri-complex inhibitor. Proof-of-concept that a single agent can cover G12D/G12V/G12C/G12R simultaneously — covering ~90% of all KRAS-mutant PDAC. FDA Breakthrough Therapy Designation + Orphan Drug Designation granted for previously treated metastatic PDAC with KRAS G12X mutations. Anchor trial that opened the first crack in KRAS's 30-year undruggable wall for pancreatic cancer.