On-Premises LLM-Directed Robotic Pancreaticoduodenectomy with Perioperative Daraxonrasib (RMC-6236) in KRAS-Mutated Pancreatic Ductal Adenocarcinoma

Statement of Compliance: This trial will be conducted in accordance with the protocol, the principles of the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guideline E6(R3), and all applicable United States regulations governing both the investigational drug and the investigational device, together with the Physical AI overlay that governs the on-premises large language model (LLM) directed robotic system. Because this is a combined Investigational New Drug (IND) and Investigational Device Exemption (IDE) first-in-human study, two distinct but harmonized regulatory spines apply concurrently; both are carried in full below, and neither is subordinated to the other. The Sponsor-Investigator attests that the conduct of every study activity, the protection of every enrolled participant, and the integrity of every recorded datum will satisfy the more stringent of the two spines wherever they differ.