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Label indication AUGTYRO is a kinase inhibitor indicated for the treatment of • adult patients with locally advanced or metastatic ROS1- positive non-small cell lung cancer (NSCLC). ( 1.1 ) • adult and pediatric patients 12 years of age and older with solid tumors that: • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion and • are locally advanced or metastatic or where surgical resection is likely to result in… FDA label
Also known as Oral repotrectinib (TPX-0005), BMS-986472, Oral repotrectinib (TPX-0005) capsules, Oral repotrectinib (TPX-0005) oral suspension, TPX-0005, repotrectinib (TPX-0005), Oral TPX-0005 capsules
Repotrectinib · 3 trials · 5 indications
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 | - |
| 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 |
| 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 oral small molecule being studied for locally advanced or metastatic solid tumors, including ROS1-positive non-small cell lung cancer and cancers with ALK, ROS1, or NTRK1-3 alterations. It is also being evaluated in pediatric and young adult patients with these genetic alterations.
Repotrectinib targets ROS1, NTRK1, NTRK2, and NTRK3 kinases, as well as CD74 and SDC4 fusion partners. It is a tyrosine kinase inhibitor designed to inhibit these targets in cancers driven by ROS1, NTRK, or ALK alterations.
Repotrectinib is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY.
Repotrectinib is in Phase 3 clinical development. It has not been approved by the FDA and remains investigational. The Phase 3 TRIDENT-3 trial is evaluating repotrectinib versus crizotinib in TKI-naive ROS1-positive non-small cell lung cancer.
Repotrectinib is being studied in three registered trials: NCT06140836 (Phase 3 TRIDENT-3 in ROS1-positive NSCLC), NCT04094610 (Phase 1 in pediatric and young adult patients with ALK, ROS1, or NTRK1-3 alterations), and NCT03093116 (Phase 1 in advanced solid tumors with ALK, ROS1, or NTRK1-3 rearrangements).
Yes, repotrectinib is also known as TPX-0005. Oral repotrectinib (TPX-0005) refers to the same investigational drug candidate.