D3 Bio announced FDA IND clearance for D3S‑003, its KRAS G12D selective inhibitor, enabling a first‑in‑human Phase I study in patients with advanced solid tumors harboring KRAS G12D mutations. The clearance clears the regulatory hurdle to initiate dose‑escalation and safety assessments in a genetically defined cohort. KRAS G12D is a prevalent oncogenic driver across pancreatic, colorectal and other solid tumors; selective inhibitors targeting this mutant remain a high priority for oncology pipelines. D3 Bio’s IND positions the company to test clinical pharmacology, target engagement and early efficacy signals in an oft‑intractable patient population. Investors and partners will watch trial design, biomarker strategy and combination plans closely—especially given competition in KRAS‑directed therapies and the importance of tolerability and durable responses in solid tumors.