D3 Bio received FDA IND clearance for D3S‑003, a KRAS G12D small‑molecule inhibitor, enabling first‑in‑human phase I studies in patients with advanced solid tumors harboring KRAS G12D mutations. The clearance permits enrollment of patients across dose‑escalation cohorts to assess safety, pharmacokinetics and preliminary efficacy. KRAS G12D is a prevalent oncogenic driver in pancreatic and colorectal cancers, and an IND greenlight signals regulatory acceptance of preclinical safety and CMC data. The dossier’s clearance places D3 Bio among a focused group of companies progressing direct KRAS inhibitors into the clinic; early clinical data will determine competitive positioning against other KRAS‑directed programs. Investigators will monitor objective response, tolerability and biomarker signals in tumor and circulating DNA.