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Also known as Zidesamtinib (NVL-520), NVL-520
Zidesamtinib · 1 trial · 2 indications
Highest dose with dose-limiting toxicity (DLT) rate ≤ 25%
To determine the RP2D
To determine ORR as assessed by BICR
| Arm | Type | Description |
|---|---|---|
| Phase 1 dose escalation | EXPERIMENTAL | Zidesamtinib (NVL-520) oral daily dosing |
| Cohort 2a | EXPERIMENTAL | ROS1+ NSCLC naïve to TKI therapy and up to 1 prior chemotherapy and/or immunotherapy |
| Cohort 2b | EXPERIMENTAL | ROS1+ NSCLC treated with 1 prior ROS1 TKI and no prior chemotherapy or immunotherapy |
| Cohort 2c | EXPERIMENTAL | ROS1+ NSCLC treated with 1 prior ROS1 TKI and 1 prior platinum-based chemotherapy with or without immunotherapy |
| Cohort 2d | EXPERIMENTAL | ROS1+ NSCLC treated with ≥2 prior ROS1 TKIs and up to 1 prior chemotherapy and/or immunotherapy |
| Cohort 2e | EXPERIMENTAL | ROS1+ solid tumor and progressed on any prior therapy |
| Name | Type | Description |
|---|---|---|
| Zidesamtinib (NVL-520) | DRUG | Oral tablet of zidesamtinib (NVL-520) |
Inclusion Criteria: 1. Age ≥18 years (Cohort 2e only: Age ≥12 years). 2. Disease Criteria: 1. Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with documented ROS1 rearrangement. 2. Phase 2: Cohorts 2a, 2b, 2c and 2d: Histologically or cytological...
Zidesamtinib is an investigational small molecule kinase inhibitor being developed by Nuvalent, Inc. for locally advanced and metastatic solid tumors. It is designed for patients whose tumors harbor a ROS1 rearrangement, a biomarker-selected population. Zidesamtinib has received Orphan Drug designation from the FDA and is currently in Phase 1 clinical development.
Zidesamtinib is being studied for the treatment of locally advanced and metastatic solid tumors that harbor a ROS1 rearrangement, including advanced non-small cell lung cancer. It is an investigational therapy and has not been approved for any indication. Treatment is directed at biomarker-selected patients whose tumors test positive for ROS1 rearrangement.
Zidesamtinib is a kinase inhibitor, a small molecule in the -tinib class, directed at ROS1-rearranged tumors. It is being developed for patients whose cancers carry a ROS1 rearrangement, which is the biomarker used to select patients for treatment in its clinical program.
Zidesamtinib is being developed by Nuvalent, Inc., a biopharmaceutical company that trades under the ticker symbol NUVL. Nuvalent is the sponsor of the clinical program evaluating the drug in ROS1-rearranged solid tumors.
Zidesamtinib is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The FDA has granted Zidesamtinib Orphan Drug designation. The Phase 1 program is currently recruiting participants.
Zidesamtinib is being evaluated in the ARROS-1 trial, registered as NCT05118789, titled A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement. The Phase 1 trial is recruiting, with an enrollment of 359 participants across the United States, Europe, Asia, and Australia.
Yes, Zidesamtinib is also known as NVL-520. Both names refer to the same investigational kinase inhibitor developed by Nuvalent, Inc. The ARROS-1 clinical trial lists the drug as Zidesamtinib (NVL-520), and the two names are used interchangeably in reference to this ROS1-targeted therapy.