Mekanistic Therapeutics reported that the FDA cleared an IND for MTX-531, the company’s lead oncology candidate, marking the start of a Phase 1 study in patients with advanced solid tumors featuring dysregulated EGFR and/or PI3K signaling. The trial is expected to begin in the third quarter. MTX-531 is designed to address tumor biology driven by coordinated EGFR and PI3K pathway activation, with investigators enrolling across solid-tumor types including head and neck and endometrial cancers. The IND clearance advances a program that earlier-stage development had positioned as a next internal oncology candidate. The company’s next reads will likely focus on safety, dosing and early biomarker-linked activity as MTX-531 enters first-in-human evaluation.