Phase 1/2 Study of LOXO-195 in Patients With Previously Treated NTRK Fusion Cancers
DFCI Protocol ID: 17-481
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.
Massachusetts General Hospital, Children's Hospital Boston, Dana-Farber Cancer Institute
Anna Farago, MD, PhD,
Massachusetts General Hospital
Steven Dubois MD,
Dana Farber Cancer Institute
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute:
Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, email@example.com
Key Inclusion Criteria:
- Advanced solid tumor for which, in the opinion of the Investigator, no other standard
or investigational therapy offers greater benefit.
- A solid tumor diagnosis in the setting of:
1. a documented NTRK fusion and a clinical history of relapse following a response
to a prior TRK inhibitor
2. a documented NTRK fusion unresponsive to a prior TRK inhibitor
3. a documented NTRK fusion and a clinical history of intolerance to a prior TRK
- 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 therapy 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.