for people ages 1 month and up (full criteria)
study started
estimated completion



This is a Phase 1/2, multi-center, open-label study designed to evaluate the safety and efficacy of LOXO-195 when administered orally to patients age ≥ 1 month and older with NTRK fusion cancers treated with a prior TRK inhibitor.

Official Title

A Phase 1/2 Study of the TRK Inhibitor LOXO-195 in Adult and Pediatric Subjects With Previously Treated NTRK Fusion Cancers


The trial will be conducted in 2 parts: dose escalation (Phase I ) and dose expansion (Phase 2) . Patients with unresectable or metastatic solid tumors are eligible if progressed or intolerant to prior TRK inhibitor. During Phase 1, a maximum tolerated dose (MTD)/recommended dose for further study will be identified for in patients age 12 and older and patients age <12. During Phase 2, the same patient population as designated for Phase 1 will be treated with the dose of LOXO-195 which has been identified during phase 1 to assess specified endpoints.


Carcinoma, Non-Small-Cell LungThyroid NeoplasmsSarcomaColorectal NeoplasmsSalivary Gland NeoplasmsBiliary Tract NeoplasmsBrain Neoplasm, PrimaryMelanomaGlioblastomaBile Duct NeoplasmsAstrocytomaHead and Neck Squamous Cell CarcinomaPontine GliomaPancreatic NeoplasmsOvarian NeoplasmsCarcinoma, Renal CellCholangiocarcinomaSkin CarcinomaCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms, Nerve TissueNevi and MelanomasIntestinal NeoplasmsThyroid CancerGISTMalignant Peripheral Nerve Sheath TumorsBreast Secretory CarcinomaUterine NeoplasmsFibrosarcomaInfantile FibrosarcomaCongenital Mesoblastic NephromaCentral Nervous System NeoplasmsNTRK Fusion PositiveLOXO-195LoxoTRKTRK FusionNTRK1NTRK2NTRK3TRKATRKBTRKCNTRKETV6fusiontumorsCNS tumorssolid tumorscentral nervous system tumorsadvanced cancerprimary CNS tumorAdvanced CNS tumorMetastatic CNS tumorNTRK1 fusionNTRK2 fusionNTRK3 fusionETV6-NTRK3ETV6 fusionMetastatic cancerCancer of Unknown Primary SitePediatricNTRK1 gene rearrangementNTRK2 gene rearrangementNTRK3 gene rearrangementETV6 gene rearrangementNTRK gene rearragementsCongenital NephromaMetastatic Infantile FibrosarcomaAdvanced Infantile FibrosarcomaCarcinomaNeoplasmsCarcinoma, Squamous CellThyroid DiseasesSquamous Cell Carcinoma of Head and NeckBrain NeoplasmsNervous System NeoplasmsNerve Sheath NeoplasmsNeurofibrosarcomaNephroma, Mesoblastic9-Fluoro-15-methyl-2,11,16,20,21,24-hexaazapentacyclo(,6.07,12.021,25)pentacosa-1(24),7,9,11,18(25),19,22-heptaen-17-one


For people ages 1 month and up

Key Inclusion Criteria:

  • Advanced solid tumor for which, in the opinion of the Investigator, no other standard therapy offers greater benefit.
  • A solid tumor diagnosis in the setting of:
  • a documented NTRK fusion and a clinical history of relapse following a response to a prior TRK inhibitor
  • a documented NTRK fusion unresponsive to a prior TRK inhibitor
  • a documented NTRK fusion and a clinical history of intolerance to a prior TRK inhibitor
  • NTRK gene fusions will be identified via a CLIA certified (or equivalent) laboratory.

Exception: Patients with Infantile Fibrosarcoma (IFS) and congenital mesoblastic nephroma (CMN) may be enrolled based on ETV6+ FISH test without identifying NTRK3

  • Performance Status: Eastern Cooperative Oncology Group (ECOG) score ≤ 3 (age ≥16) or Lansky Performance Score (LPS) ≥40% (age<16). If enrolled with primary CNS tumor to be assessed by RANO, Karnofsky Performance Status (KPS) (age ≥16) or LPS (age<16) ≥ 50%
  • Life expectancy > 4 weeks
  • Adequate hematologic, hepatic and renal function.
  • Patients with stable CNS primary tumor, brain metastases, or treated spinal cord compression are eligible if neurological symptoms and steroid use (if applicable) have been stable for 7 days prior to the first dose of LOXO-195
  • Ability to receive study drug orally or by enteral administration

Key Exclusion Criteria:

  • Required treatment with certain strong CYP3A4 inhibitors or inducers.
  • Clinically significant active cardiovascular disease or history of myocardial infarction within 3 months prior to planned start of LOXO-195 or prolongation of the QT interval corrected (QTcF) > 480 msec within the past 6 months
  • Major surgery within 7 days of enrollment
  • Uncontrolled systemic bacterial, fungal or viral infection
  • Pregnancy or lactation.
  • Known hypersensitivity to any of the components of LOXO-195 or Ora-Sweet® SF and OraOlus, for patients receiving liquid suspension


  • University of California, Los Angeles accepting new patients
    Los AngelesCalifornia90095United States
  • Stanford Cancer Center accepting new patients
    StanfordCalifornia94304United States


accepting new patients
Start Date
Completion Date
Loxo Oncology, Inc.
Phase 1/2
Study Type
Last Updated