Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NVL-330 · 1 trial · 2 indications
To determine up to 2 RP2D Candidates
If applicable, to determine the MTD
Number of participants with TEAEs as assessed by CTCAE, v5.0
| Arm | Type | Description |
|---|---|---|
| Phase 1a dose escalation | EXPERIMENTAL | NVL-330 oral daily dosing |
| Phase 1b dose expansion | EXPERIMENTAL | NVL-330 oral daily dosing |
| Name | Type | Description |
|---|---|---|
| NVL-330 | DRUG | Oral Tablet of NVL-330 |
Inclusion Criteria: 1. Age ≥ 18 years 2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC 3. Documented HER2 status as follows: 1. Phase 1a: Documented oncogenic HER2 mutation such as HER2 exon20 insertion mutations or single nucleotide variants or HER2 amplificati...
NVL-330 is an investigational small molecule being developed for the treatment of locally advanced solid tumors. It is currently being studied in patients with advanced or metastatic HER2-altered non-small cell lung cancer (NSCLC) as part of the HEROEX-1 clinical trial.
NVL-330 targets HER2, a protein that can drive tumor growth when altered. By targeting HER2, NVL-330 is designed to interfere with cancer cell signaling. It is being evaluated in patients with HER2-altered tumors, including those with advanced or metastatic NSCLC.
NVL-330 is being developed by Nuvalent, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol NUVL. The company is conducting clinical trials to evaluate the safety and efficacy of NVL-330 in patients with HER2-altered solid tumors.
NVL-330 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting patients to assess the drug's safety, tolerability, and preliminary activity.
NVL-330 is being studied in the HEROEX-1 trial, registered as NCT06521554. This Phase 1 study is recruiting approximately 200 patients with advanced or metastatic HER2-altered NSCLC and is being conducted in the United States, Australia, and Canada.
No, NVL-330 is the drug being studied, while HEROEX-1 is the name of the clinical trial evaluating it. The trial, identified as NCT06521554, is a Phase 1 study of NVL-330 in patients with advanced or metastatic HER2-altered NSCLC.