A Phase 1 Study of Oral LOXO-292 in Patients With Advanced Solid Tumors, Including RET-Fusion Non-Small Cell Lung Cancer, Medullary Thyroid Cancer, and Other Tumors With Increased RET Activity
Skin Cancer (Non-Melanoma)
12 Years and older, Male and Female
This is a Phase 1, open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of LOXO-292 administered orally to patients with advanced solid tumors, including RET-fusion non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other tumors with increased RET activity.
The trial will be conducted in 2 parts: dose escalation (Part 1) and dose expansion (Part 2).
During Part 1, patients with advanced NSCLC, advanced MTC or other advanced solid tumors are
initially eligible if the tumor has progressed following or has not adequately responded to
standard therapy, or if the patient is intolerant of, unlikely to benefit from or refuses
standard therapy. During Part 2, patients with NSCLC, MTC or other advanced solid tumor that
harbors a RET gene alteration or other evidence of increased RET activity are eligible.