All cancers begin when one or more genes change/rearrange and the cell starts to divide and grow out of control. Identifying these abnormal genes is important, because drugs can be developed to target and stop them.
A ROS1 rearrangement is an abnormality in a gene that can occur in cancer cells such as in lung cancer cells. NTRK+ gene abnormalities can occur in various solid tumor cancers.
TRIDENT-1 is a clinical study that is evaluating whether repotrectinib is effective in ROS1+ advanced non-small cell lung cancer and TRK+ (i.e. NTRK1-3) advanced solid tumors.
Cancer cells often develop mutations (changes in the genetic material of a cell) that prevent entry for TKIs to hit their target. Repotrectinib was designed to inhibit (block) rearranged forms of ROS1 and TRK and was also designed to be small enough to potentially bypass the barriers caused by two common types of mutations: 1) solvent front and 2) gatekeeper. The TRIDENT-1 study is evaluating repotrectinib in individuals with non-small cell lung cancer who have tested positive for ROS1, and in individuals with advanced solid tumor cancers that have tested positive for TRK.
Repotrectinib comes in pill form and is taken by mouth.
In order to participate you will need to be evaluated to determine if you are eligible to participate. It may take up to 28-days to evaluate whether you are eligible for the study.
If you are eligible to participate, you will take the investigational drug daily for 28 days in each cycle (28-day cycles* = approximately one month)
*There is no maximum duration for this study. You can continue with your cycles of study treatment until any of the following occur: your disease worsens, you decide to no longer participate in the study, the study doctor decides you should no longer participate in the study, the study sponsor decides to stop the study.
FOLLOW UP PERIOD:
Once you stop taking the investigational drug, we would like to perform a follow-up visit to see how you are doing. The follow-up visit will occur 28 days after your last dose of investigational drug, and then a check-in via phone every 3 months.
A clinical study is a type of research study designed to evaluate whether an investigational drug is safe and effective for use in humans. Participants are given specific investigational treatments and researchers closely monitor the results to help determine if the drug should be approved for wider use. The U.S. Food and Drug Administration (FDA) has strict rules that govern how clinical studies are conducted, and requires that an investigational drug be proven safe and effective before it can be widely used in the United States.
An investigational drug is a drug that has not been approved by the U.S. Food and Drug Administration (FDA) but can be administered to people in a clinical study for research purposes.
TRIDENT-1 is a phase 1/2 clinical study evaluating an investigational drug repotrectinib for the treatment of participants with ROS1+ advanced non-small cell lung cancer (NSCLC) as well as participants with NTRK+ advanced solid tumors. There is no cost to participants to be in the study and there is no maximum duration for this study. You can continue with your cycles of study treatment until any of the following occur: your disease worsens, you decide to no longer participate in the study, the study doctor decides you should no longer participate in the study, the study sponsor decides to stop the study.
Current U.S. study locations are listed below, and more may be added as they open. If you are interested in participating in the TRIDENT-1 study, complete the form to speak with a study representative who can also provide available study locations.