Investigational New Drug Application - Daraxonrasib, Phase 1, LLM-Directed Robotic Whipple in KRAS-Mutated PDAC

On behalf of ChemicalQDevice, and in my capacity as sponsor-investigator, I am submitting this initial Investigational New Drug Application (IND v1.0) under 21 CFR §312.23 for a Phase 1, first-in-human, prospective open-label single-arm study of daraxonrasib (RMC-6236), an oral once-daily RAS(ON) multi-selective (pan-RAS) small-molecule inhibitor, administered in the perioperative setting of a large language model (LLM) directed eight-arm robotic pancreaticoduodenectomy (Whipple) for patients with resectable or borderline-resectable, KRAS G12 mutated pancreatic ductal adenocarcinoma (PDAC). This application is assigned serial number 0000 as the initial submission and is transmitted with FDA Form 1571 as the cover sheet for the submission and the sponsor agreement, together with FDA Form 3674 (clinicaltrials.gov certification) and FDA Form 1572. The mechanistic premise is well established: daraxonrasib binds GTP-bound active mutant RAS in complex with cyclophilin A and thereby suppresses downstream effector signaling, and the agent received FDA Breakthrough Therapy designation in June 2025 for previously treated metastatic PDAC bearing KRAS G12 alterations.