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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Phase 1 / 2 Study of LOXO-292 in Patients With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer

This is a Phase 1 / 2, 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 patients with advanced solid tumors, including RET-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.
Phase I/II
Mol. targeted/Immunotherapy/Biologics
LOXO-292 (Selpercatinib)
Berlin, Jordan
Vanderbilt University


12 Years
Inclusion Criteria:

Key Inclusion Criteria: For Phase 1 - Patients with a locally advanced or metastatic solid tumor who: - have progressed on or are intolerant to standard therapy, or - no standard therapy exists, or in the opinion of the Investigator, are not candidates for or would be unlikely to tolerate or derive significant clinical benefit from standard therapy, or - decline standard therapy - Prior MKIs with anti-RET activity are allowed. - A RET gene alteration is not required initially. Once adequate PK exposure is achieved, evidence of RET gene alteration in tumor and/or blood is required as identified through molecular assays, as performed for clinical evaluation. - Measurable or non-measurable disease as determined by RECIST 1.1 or RANO as appropriate to tumor type. - Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2 or Lansky Performance Score (LPS) ? 40% (age 470 msec. - Required treatment with certain strong CYP3A4 inhibitors or inducers and certain prohibited concomitant medications.

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