Turning Point Therapeutics Initiates Phase 2 Registrational Portion of TRIDENT-1 Clinical Study
Patients will be treated with Turning Point’s lead investigational kinase inhibitor, repotrectinib, which has been studied in more than 80 patients in the ongoing Phase 1 portion of the study.
“Following the Phase 1 results presented last month at the
The study is planned for global site expansion during 2019 and into 2020 at approximately 100 sites.
Screening for the study will involve genetic testing of a sample of the patient’s tumor to identify the presence of genetic alterations, such as ROS1 or NTRK, to determine eligibility for the trial. Repotrectinib is being developed as a precision therapy targeting ROS1 and NTRK-driven cancers.
“Initiation of the Phase 2 registrational portion of TRIDENT-1 is a big step toward getting repotrectinib to many more patients globally who currently have limited treatment options,” said Athena Countouriotis, M.D, chief executive officer of
Patients eligible for the study will receive the likely recommended Phase 2 dose of 160 mg of repotrectinib once or twice daily, pending upcoming feedback from the
More information about the TRIDENT-1 study is available at https://www.clinicaltrials.gov/ct2/show/NCT03093116?term=tpx-0005&rank=1.
Repotrectinib is an investigational next-generation TKI designed to target ROS1 and TRK A/B/C and systemically overcome resistant mutations that invariably result following treatment with other TKIs. In the U.S. and
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of repotrectinib, the results, conduct and timing of Turning Point Therapeutics’ Phase 1/2 TRIDENT-1 clinical study, plans regarding future clinical trials and the regulatory approval path for repotrectinib. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “plans”, “will”, “believes,” “anticipates,” “expects,” “intends,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Turning Point Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Turning Point Therapeutics’ business in general, and the other risks described in Turning Point Therapeutics’ filings with the
Source: Turning Point Therapeutics, Inc.