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Last Updated: December 25, 2024

CLINICAL TRIALS PROFILE FOR REPOTRECTINIB


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All Clinical Trials for REPOTRECTINIB

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03093116 ↗ A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements Recruiting TP Therapeutics, Inc. Phase 1/Phase 2 2017-02-27 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.
NCT03093116 ↗ A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements Recruiting Turning Point Therapeutics, Inc. Phase 1/Phase 2 2017-02-27 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.
NCT04094610 ↗ A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations Recruiting Turning Point Therapeutics, Inc. Phase 1/Phase 2 2020-03-20 Phase 1 will evaluate the safety and tolerability at different dose levels of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring anaplastic lymphoma kinase (ALK), receptor tyrosine kinase encoded by the gene ROS1 (ROS1), or neurotrophic receptor kinase genes encoding TRK kinase family (NTRK1-3) alterations to estimate the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and select the Pediatric Recommended Phase 2 Dose (RP2D). Phase 2 will determine the anti-tumor activity of repotrectinib in pediatric subjects with advanced or metastatic malignancies harboring ALK, ROS1, or NTRK1-3 alterations.
NCT04772235 ↗ Phase I Study of Repotrectinib and Osimertinib in NSCLC Patients Not yet recruiting Turning Point Therapeutics, Inc. Phase 1 2021-04-01 This is a Phase I study of repotrectinib in combination with osimertinib in patients with advanced or metastatic EGFR mutant non small cell lung cancer (NSCLC). The study will be conducted in 2 parts, Part Ia and Part Ib, and its purpose will be to find the incidence of dose-limiting toxicities (DLTs) as defined by the primary safety and tolerability endpoint. The Phase Ia study will also determine the impact of repotrectinib on osimertinib pharmacokinetics (PK) and the maximum tolerated dose (MTD), if reached, of repotrectinib given in combination with osimertinib and the recommended Phase II dose (RP2D). Dose escalation will be conducted according to a 'Rolling-6' based study design with 3 dose levels for repotrectinib: 80 mg once a day (QD), 160 mg QD or 160 mf QD during 14 days followed by 160 mg twice a day (BID); in combination with 80 mg QD of osimertinib. A total of 6 patients will be enrolled in each dose level cohort. In addition, this Phase Ib study will test early drug activity (efficacy) of the proposed combination treatment in an expansion cohort at the RP2D.
NCT04772235 ↗ Phase I Study of Repotrectinib and Osimertinib in NSCLC Patients Not yet recruiting Instituto Oncológico Dr Rosell Phase 1 2021-04-01 This is a Phase I study of repotrectinib in combination with osimertinib in patients with advanced or metastatic EGFR mutant non small cell lung cancer (NSCLC). The study will be conducted in 2 parts, Part Ia and Part Ib, and its purpose will be to find the incidence of dose-limiting toxicities (DLTs) as defined by the primary safety and tolerability endpoint. The Phase Ia study will also determine the impact of repotrectinib on osimertinib pharmacokinetics (PK) and the maximum tolerated dose (MTD), if reached, of repotrectinib given in combination with osimertinib and the recommended Phase II dose (RP2D). Dose escalation will be conducted according to a 'Rolling-6' based study design with 3 dose levels for repotrectinib: 80 mg once a day (QD), 160 mg QD or 160 mf QD during 14 days followed by 160 mg twice a day (BID); in combination with 80 mg QD of osimertinib. A total of 6 patients will be enrolled in each dose level cohort. In addition, this Phase Ib study will test early drug activity (efficacy) of the proposed combination treatment in an expansion cohort at the RP2D.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for REPOTRECTINIB

Condition Name

Condition Name for REPOTRECTINIB
Intervention Trials
Metastatic Solid Tumor 4
Locally Advanced Solid Tumors 2
Metastatic Solid Tumors 2
Advanced Solid Tumor 2
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Condition MeSH

Condition MeSH for REPOTRECTINIB
Intervention Trials
Neoplasms 6
Carcinoma, Non-Small-Cell Lung 2
Lung Neoplasms 1
Central Nervous System Neoplasms 1
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Clinical Trial Locations for REPOTRECTINIB

Trials by Country

Trials by Country for REPOTRECTINIB
Location Trials
United States 51
China 38
Spain 11
France 9
Japan 9
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Trials by US State

Trials by US State for REPOTRECTINIB
Location Trials
Ohio 4
New York 4
Colorado 3
Texas 3
Massachusetts 3
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Clinical Trial Progress for REPOTRECTINIB

Clinical Trial Phase

Clinical Trial Phase for REPOTRECTINIB
Clinical Trial Phase Trials
Phase 3 1
Phase 1/Phase 2 4
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for REPOTRECTINIB
Clinical Trial Phase Trials
Recruiting 7
Not yet recruiting 1
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Clinical Trial Sponsors for REPOTRECTINIB

Sponsor Name

Sponsor Name for REPOTRECTINIB
Sponsor Trials
Turning Point Therapeutics, Inc. 6
Memorial Sloan Kettering Cancer Center 1
Zai Lab (Shanghai) Co., Ltd. 1
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Sponsor Type

Sponsor Type for REPOTRECTINIB
Sponsor Trials
Industry 9
Other 2
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