This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of pralsetinib (BLU-667) administered orally in participants with medullary thyroid cancer (MTC), RET-altered NSCLC and other RET-altered solid tumors.
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Phase 1 : Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Pralsetinib
Timeframe: Up to approximately 30.8 months
Phase 1 and Phase 2: Number of Participants With AEs and Serious AEs (SAEs)
Timeframe: From Cycle 1 Day 1 up to 30 days after the final dose of study drug (up to approximately 6.7 years)
Phase 2: Overall Response Rate (ORR)
Timeframe: Up to approximately 79.8 months