Daraxonrasib in Resectable PDAC

This is a DF/HCC PI-sponsored Phase 1 interventional treatment trial in resectable pancreatic ductal adenocarcinoma. Participants are screened before starting treatment and then assigned to one of two protocol-defined cohorts that differ in the duration of neoadjuvant daraxonrasib before surgery. Study treatment includes oral daraxonrasib once daily during 28-day cycles before surgery, followed by surgical resection, adjuvant chemotherapy with or without radiation per institutional standard and physician discretion, and optional adjuvant daraxonrasib for up to 32 cycles (24 months) after completion of adjuvant therapy. The study includes safety monitoring, tumor assessments, laboratory testing, collection of archival tumor tissue, research blood and stool, and sharing of de-identified data and biospecimens with outside collaborators for analysis and future research. Planned accrual is 30 participants over 24 months, with post-treatment follow-up at least every 6 months for up to 5 years.