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Also known as Oral repotrectinib (TPX-0005)
Repotrectinib · 6 trials · 7 indications
Probe substrate contains metformin, digoxin, and rosuvastatin.
Probe substrate contains metformin, digoxin, and rosuvastatin.
Probe substrate contains metformin, digoxin, and rosuvastatin.
Probe substrate contains metformin, digoxin, and rosuvastatin.
Probe substrate contains metformin, digoxin, and rosuvastatin
Probe substrate contains metformin, digoxin, and rosuvastatin
Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)
Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)
Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)
Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)
Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)
Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)
Define the dose limiting toxicities (DLTs) (Phase 1)
To determine the pediatric RP2D (Phase 1)
To determine the confirmed ORR of repotrectinib (TPX-0005) as assessed by Blinded Independent Central Review (Phase 2)
To determine the RP2D (Phase 1)
To determine the confirmed ORR of repotrectinib (TPX-0005) as assessed by Blinded Independent Central Review (Phase 2)
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | - |
| Arm B | ACTIVE_COMPARATOR | - |
| Cohort 1 | EXPERIMENTAL | - |
| Cohort 2 | EXPERIMENTAL | - |
| Part 1 | EXPERIMENTAL | - |
| Part 2 | EXPERIMENTAL | - |
| Group 1: Moderate Hepatic Impairment | EXPERIMENTAL | - |
| Group 2: Severe Hepatic Impairment | EXPERIMENTAL | - |
| Group 3: Normal Hepatic Function | EXPERIMENTAL | - |
| Repotrectinib (TPX-0005) | EXPERIMENTAL | Phase 1 Oral repotrectinib (TPX-0005): Safety and tolerability at different dose levels Phase 2 Oral repotrectinib (TPX-0005): 3 cohorts Cohort 1: TKI-naive NTRK fusion Cohort 2: Prior TKI NTRK fusion Cohort 3: ROS1 gene fusions or other ROS1 aberrations |
| Name | Type | Description |
|---|---|---|
| Repotrectinib | DRUG | Specified dose on specified days |
| Crizotinib | DRUG | Specified dose on specified days |
| Metformin | DRUG | Specified dose on specified days |
| Digoxin | DRUG | Specified dose on specified days |
| Rosuvastatin | DRUG | Specified dose on specified days |
| Bupropion | DRUG | Specified dose on specified days |
| Flurbiprofen | DRUG | Specified dose on specified days |
| Omeprazole | DRUG | Specified dose on specified days |
| Voriconazole | DRUG | Specified dose on specified days |
| Quinidine | DRUG | Specified dose on specified days |
| Oral repotrectinib (TPX-0005) | DRUG | Oral repotrectinib (TPX-0005) |
Inclusion Criteria: * Participant has histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC * Participant has a ROS1 gene rearrangement/fusion as detected by a local test. * At least 1 measurable lesion according to RECIST v1.1, as assessed by the investigator....
Repotrectinib is an investigational small molecule kinase inhibitor being studied in oncology. It is being evaluated in clinical trials for locally advanced solid tumors, metastatic solid tumors, non-small cell lung cancer, lymphoma, primary CNS tumors, and hepatic impairment. It is also studied in healthy volunteers for pharmacokinetic assessment.
Repotrectinib is a kinase inhibitor, belonging to the -tinib class of drugs. It is being studied in patients with tumors harboring ALK, ROS1, or NTRK1-3 rearrangements or alterations, indicating it targets these kinase pathways. The drug is designed to interfere with signaling driven by these genetic alterations.
Repotrectinib is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy across multiple oncology indications, including non-small cell lung cancer and various solid tumors.
Repotrectinib is in Phase 3 clinical development. It is being studied in a Phase 3 trial for ROS1-positive non-small cell lung cancer, while additional Phase 1 trials are ongoing for other indications. Repotrectinib is investigational and not yet approved by regulatory authorities.
Repotrectinib is being studied in several clinical trials. NCT03093116 is a Phase 1 trial in advanced solid tumors with ALK, ROS1, or NTRK1-3 rearrangements. NCT04094610 is a Phase 1 pediatric trial. NCT06140836 is the Phase 3 TRIDENT-3 trial versus crizotinib in NSCLC. NCT06352528 is a completed Phase 1 hepatic impairment study.
Yes, repotrectinib is also known as oral repotrectinib (TPX-0005). The drug is referred to by both names in clinical trial documentation, and TPX-0005 is the earlier development code. Researchers and investors may encounter either name when reviewing study data.