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Also known as Zidesamtinib (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 being studied for the treatment of locally advanced solid tumors, specifically in patients with advanced non-small cell lung cancer and other solid tumors that harbor ROS1 rearrangement. It is currently in Phase 1 clinical development.
Zidesamtinib is a kinase inhibitor, as indicated by its '-tinib' suffix. It is being studied in tumors that harbor ROS1 rearrangement, suggesting it targets ROS1 kinase. The drug is designed to interfere with cancer cell signaling pathways driven by this genetic alteration.
Zidesamtinib is being developed by Nuvalent, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol NUVL. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced solid tumors.
Zidesamtinib is currently in Phase 1 clinical trials. It is an investigational drug and has not yet been approved by regulatory authorities. The drug has received Breakthrough Therapy and Orphan Drug designations from the FDA, which are intended to expedite its development and review.
Zidesamtinib is being evaluated in a Phase 1 clinical trial with the identifier NCT05118789, known as the ARROS-1 study. This trial is recruiting patients with advanced NSCLC and other solid tumors harboring ROS1 rearrangement, with an enrollment target of 359 participants across multiple countries.
Yes, Zidesamtinib is also known as NVL-520. Both names refer to the same investigational drug being developed by Nuvalent, Inc. for the treatment of advanced solid tumors with ROS1 rearrangement.