This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also known as LOXO-292) administered orally to participants with advanced solid tumors, including rearranged during transfection (RET)-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.
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Phase 1: Maximum Tolerated Dose (MTD)
Timeframe: Cycle 1 (cycle length = 28 days)
Phase 1: Recommended Phase 2 Dose (RP2D)
Timeframe: Cycle 1 (cycle length = 28 days)
Phase 2: Objective Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment
Timeframe: Approximately for up to 7 years 8 months