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 Lung Thyroid Neoplasms Sarcoma Colorectal Neoplasms Salivary Gland Neoplasms Biliary Tract Neoplasms Brain Neoplasm, Primary Melanoma Glioblastoma Bile Duct Neoplasms Astrocytoma Head and Neck Squamous Cell Carcinoma Pontine Glioma Pancreatic Neoplasms Ovarian Neoplasms Carcinoma, Renal Cell Cholangiocarcinoma Skin Carcinoma Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Intestinal Neoplasms Thyroid Cancer GIST Malignant Peripheral Nerve Sheath Tumors Breast Secretory Carcinoma Uterine Neoplasms Fibrosarcoma Infantile Fibrosarcoma Congenital Mesoblastic Nephroma Central Nervous System Neoplasms NTRK Fusion Positive LOXO-195 Loxo TRK TRK Fusion NTRK1 NTRK2 NTRK3 TRKA TRKB TRKC NTRK ETV6 fusion tumors CNS tumors solid tumors central nervous system tumors advanced cancer primary CNS tumor Advanced CNS tumor Metastatic CNS tumor NTRK1 fusion NTRK2 fusion NTRK3 fusion ETV6-NTRK3 ETV6 fusion Metastatic cancer Cancer of Unknown Primary Site Pediatric NTRK1 gene rearrangement NTRK2 gene rearrangement NTRK3 gene rearrangement ETV6 gene rearrangement NTRK gene rearragements Congenital Nephroma Metastatic Infantile Fibrosarcoma Advanced Infantile Fibrosarcoma Carcinoma Neoplasms Carcinoma, Squamous Cell Thyroid Diseases Squamous Cell Carcinoma of Head and Neck Brain Neoplasms Nervous System Neoplasms Nerve Sheath Neoplasms Neurofibrosarcoma Nephroma, Mesoblastic 9-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, San Diego (UCSD) - Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States


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