D3 Bio announced FDA IND clearance for D3S‑003, a KRAS G12D small‑molecule inhibitor, clearing the path to a first‑in‑human phase I trial in advanced solid tumors harboring the KRAS G12D mutation. The IND enables dose‑escalation studies to define safety, pharmacokinetics and early efficacy signals in a mutation with high prevalence across several tumor types. The filing follows preclinical characterization positioning D3S‑003 among targeted KRAS efforts that aim to expand mutation‑specific small‑molecule options beyond existing KRAS G12C agents. D3 Bio will likely prioritize dose safety and biomarker development to guide expansion cohorts. Why it matters: IND clearance for a G12D inhibitor represents a key step for targeted oncology programs and competitive positioning in a mutation class with strong unmet need.