A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements
Recruiting now · Phase 1/Phase 2
Conditions studied: Locally Advanced Solid Tumors, Metastatic Solid Tumors
In brief
Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction. Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.
Key facts
- Study ID
- NCT03093116
- Run by
- Turning Point Therapeutics, Inc.
- People needed
- 500
- Starts
- 2017-03-07
- Expected to finish
- 2028-02-29
- Last updated by the study team
- 2026-05-27
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- The Affiliated Tumor Hospital of Harbin Medical University — Harbin, Heilongjiang, China (enrolling)
- Tangdu Hospital — Xi'an, Shan3xi, China (enrolling)
- MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- Guangdong Provincial People'S Hospital — Guangzhou, Guangdong, China (enrolling)
- Jilin Cancer Hospital/Medical Oncology Department — Changchun, Jilin, China (enrolling)
- Liaoning Cancer Hospital — Shenyang, Liaoning, China (enrolling)
- Washington University Infusion Center Pharmacy — St Louis, Missouri, United States (enrolling)
- UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (enrolling)
- The First Affiliated hospital of Xiamen University-oncology — Xiamen, Fujian, China (enrolling)
- Jilin Cancer Hospital/Medical Oncology Department — Changchun, Jilin, China (enrolling)
- Memorial Healthcare System — Hollywood, Florida, United States (enrolling)
- The first hospital of Jilin university-Oncology Department — Changchun, Jilin, China (enrolling)
- University Cancer and Blood Center — Athens, Georgia, United States (enrolling)
- St Joseph Heritage Healthcare — Santa Rosa, California, United States (enrolling)
- University of Chicago — Chicago, Illinois, United States (enrolling)
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (enrolling)
- Baptist Memorial Hospital Baptist Cancer Center — Memphis, Tennessee, United States (enrolling)
- Chris O'Brien LifeHouse — Camperdown, New South Wales, Australia (enrolling)
- Massachusetts General Hospital, — Boston, Massachusetts, United States (enrolling)
- Beijing Cancer hospital — Beijing, Beijing Municipality, China (enrolling)
- Daping Hospital, the Third Affiliated Hospital of Third Military Medical University /Cancer Center — Daping, Chongqing Municipality, China (enrolling)
- Hunan Cancer Hospital-thoracic oncology II — Changsha, Hunan, China (enrolling)
- XuZhou Central Hospital/Oncology Department — Xuzhou, Jiangsu, China (enrolling)
- Shanxi Bethune Hospital — Taiyuan, Shanxi, China (enrolling)
Full record on ClinicalTrials.gov
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