This study is searching for participants with advanced solid tumors to try a new treatment called repotrectinib (TPX-0005). The main outcomes that will be measured include side effects, the most effective dose and response. This trial is recruiting in the United States and Korea.
The details
Patients with different genetic mutations (abnormalities) responded differently to different anti-cancer treatments. Anti-cancer drugs called a tyrosine kinase inhibitors (TKIs) are commonly used to treated solid cancers.
This study will investigate how effective and safe a new therapy, repotrectinib, is in advanced solid tumors with specific mutations. Side effects that may affect the dose of the treatment in the 28 days after therapy, the most effective treatment dose and overall response in the two years after treatment will be measured.
Who are they looking for?
The study will recruit 450 participants with advanced solid tumors. Participants must have a mutation in one of the following genes: ALK, ROS1, NTRK1, NTRK2, or NTRK3. Those who have undergone chemotherapy or immunotherapy can participate if all side effects have disappeared. To be included participants must have adequate blood tests.
Those participating in another clinical trial will not be included. Those with a cancer that has spread to the brain or the membranes around the brain or spinal cord will not be included. If a patient has undergone surgery within 4 weeks of the study start they cannot participate. Other exclusion criteria are active infections, digestive system, and lung diseases or nerve disease.
How will it work
There will be 2 phases in this study. Those taking part in phase 1 will receive repotrectinib in increasing doses, in combination with food and in increasing doses, with food and the anti-cancer drug midazolam (Versed). Those participating in phase 2 will be split into 6 groups depending on their gene mutation. All participants will be treated with repotrectinib.
Patients will be followed up for up to 3 years to measure side effects and overall response to treatment.
