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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 being studied for use in oncology. It is being evaluated in clinical trials for locally advanced solid tumors, non-small-cell lung cancer, and carcinoma. It is also being studied in healthy volunteers and in participants with hepatic impairment to assess drug levels.
Repotrectinib is a kinase inhibitor that targets ROS1 and the NTRK family, including NTRK1, NTRK2, and NTRK3. It also interacts with CD74 and SDC4, which are fusion partners commonly associated with these kinases in certain cancers.
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 in various oncology indications.
Repotrectinib is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The development program includes multiple Phase 1 studies and a Phase 3 trial for oncology indications.
Repotrectinib is being studied in several trials, including NCT04094610, a Phase 1 study in pediatric and young adult subjects with ALK, ROS1, or NTRK1-3 alterations. Other trials include NCT06352528, NCT06493409, and NCT07223671, which assess drug levels and interactions in healthy participants and those with hepatic impairment.
Yes, Repotrectinib is also known as oral repotrectinib (TPX-0005). Researchers and clinical trial documents may refer to the drug by either name, but they describe the same investigational compound.