Phase 1  | 


Lung Cancer, Medullary Thyroid Cancer, or Other Advanced Solid Tumors

Next-Generation RET Inhibitor

A Phase 1 Study of Oral LOXO-260 in Patients with RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors With RET Activation Refractory to Selective RET Inhibitors*

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Key Inclusion Criteria
  • ≥18 years of age at the time of signing the informed consent (phase 1a and phase 1b). Patients 12 years and older may be enrolled in phase 1b for countries and sites where approved
  • Evidence of a previously documented RET fusion (solid tumors) or RET mutation (MTC or MEN2-associated cancers) that is a histological or a cytological proven diagnosis of locally advanced, unresectable and/or metastatic cancer and meet cohort-specific criteria
  • Prior treatment with selective RET inhibitor
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 (age >16 years), Karnofsky Performance Status (KPS) ≥80 (age >16 years), or Lansky Performance Status (LPS) ≥40% (age <16 years)
  • Discontinued all previous treatments for cancer with resolution of any significant adverse events (AEs) and of all clinically significant toxic effects of prior locoregional therapy, surgery, radiotherapy, or systemic anticancer therapy
  • Adequate organ function
  • Phase 1b (dose expansion): Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Phase 1b (dose expansion): Molecular pathology results (including RET and other genes) from a sample (blood or tissue) taken on or after RET selective treatment

Key Exclusion Criteria
  • Disease suitable for local therapy administered with curative intent
  • Active fungal, bacterial, and/or active untreated viral infection
  • Serious preexisting medical condition(s)
  • Symptomatic central nervous system (CNS) malignancy or metastasis
  • Treatment with drugs known to be strong inhibitors or inducers of cytochrome P450 3A (CYP3A)
  • Progression of disease within 4 months of starting a prior selective RET inhibitor
  • Phase 1b (dose expansion): Patients harboring known activating bypass alterations outside RET that may confer resistance to LOXO-260
This clinical trial is being conducted in the United States.
LOXO-260 is administered PO.
Contact the Loxo Oncology at Lilly Clinical Trial Team

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The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.