Bayer 20810 - A Phase 1/2 Study of the TRK Inhibitor BAY 2731954 in Adult and Pediatric Subjects with Previously Treated NTRK Fusion Cancers. Formerly: LOXO-EXT-17005 - A Phase 1/2 Study of the TRK Inhibitor LOXO-195 in Adult and Pediatric Subjects with Previously Treated NTRK Fusion Cancer

Protocol # :
Solid Tumors Harboring NTRK Fusion
Disease Sites
Lip, Oral Cavity and Pharynx
Small Intestine
Other Digestive Organ
Other Respiratory and Intrathoracic Organs
Bones and Joints
Soft Tissue
Mycosis Fungoides
Other Skin
Corpus Uteri
Other Female Genital
Other Male Genital
Urinary Bladder
Other Urinary
Eye and Orbit
Brain and Nervous System
Unknown Sites
Ill-Defined Sites
Other Endocrine System
Kaposi's Sarcoma
Melanoma, Skin
Principal Investigator
Lin, Jessica
Site Investigator
Demetri, George, D.
Dubois, Steven
Site Research Nurses
Aspri, Tristan
Blaikie, Anna, Rose
Boudreault, Teresa
Caramella, Anne
Carr, Margaret, M.
Carrier, Amy
Cavanaugh, Kerri, Lynn
Channell, Kelly
DeGonge, Danielle
Delrosso, Alexandria, P.
Ezrre, Suzanne
Gillen Mckay, Christine, A.
Harran, John
Hedglin, Jennifer
Lundin, Aishlinn
Lundin, Aishlinn
Lundquist, Debra
Ly, Christina
Mackey, Kathleen
Mossali, Alexandra
Powers, Allison
Rang, Bethany
Rattner, Barbara, A.
Rowan, Jennifer, M.
Spriggs, Kristen
Turbini, Victoria, L.
White, Laura
Wood, Valerie, J.

Trial Description

This research study is done to test the safety of the new drug selitrectinib in children and
adults with cancer having a change in a particular gene (NTRK1, NTRK2 or NTRK3). The drug may
treat cancer by interfering with the effect of the NTRK genes on cancer growth. The study
also investigates how the drug is absorbed and processed in the human body, and how well and
for how long the cancer responds to the drug. This is the first study to test selitrectinib
in humans with cancer, for whom no other effective therapy exists.

Eligibility Requirements

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) a documented NTRK fusion and a clinical history of relapse following a
response to a prior TRK inhibitor

- b) a documented NTRK fusion unresponsive to a prior TRK inhibitor

- c) a documented NTRK fusion and a clinical history of intolerance to a prior TRK

- NTRK gene fusions will be identified in a CLIA-certified (or equivalently-accredited
diagnostic) laboratory. If such a report cannot be provided, other available
certifications/accreditations are required and need to be documented. Patients with
infantile fibrosarcoma (IFS) or congenital mesoblastic nephroma (CMN) may be enrolled
based on an ETV6+ FISH test without identifying NTRK3.

- Performance Status: Eastern Cooperative Oncology Group (ECOG) score ≤ 2 in adults or
Karnofsky Performance Status (KPS) Score≥50% (age ≥ 16 years) or Lansky Performance
Score (LPS) ≥ 40% (age < 16 years).

- Life expectancy of at least 3 months.

- Adequate hematologic, hepatic and renal function.

- Patients with stable central nervous system (CNS) primary tumor, brain metastases, or
treated spinal cord compression are eligible if neurological symptoms have been stable
for 7 days prior to the first dose of selitrectinib.

- Ability to receive study drug orally or by enteral administration

Exclusion Criteria:

- Prior exposure to second generation TRK inhibitor (e.g. selitrectinib, repotrectinib
[TPX-0005]), taletrectinib [DS-6501b/AB-106]). Exception is in case patient presented
intolerance to the second generation TRK inhibitor agent and the duration of exposure
was less than 28 days. No previous treatment with selitrectinib is allowed.

- Concurrent treatment with a strong CYP3A4 inhibitor or inducer, consumption of
grapefruit juice or Seville oranges, or drugs associated with QT prolongation.

- Clinically significant active cardiovascular disease or history of myocardial
infarction within 3 months prior to planned start of selitrectinib, or prolongation of
QT interval corrected for heart rate (QTc interval) >480 milliseconds within past 6

- Major surgery within 7 days of enrollment

- Uncontrolled systemic bacterial, fungal or viral infection.

- Pregnancy or lactation.

- Known hypersensitivity to selitrectinib or Ora-Sweet® SF and OraPlus® for patients
receiving liquid formulation.