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 developed by Nuvalent, Inc. for locally advanced and metastatic solid tumors, including HER2-altered non-small cell lung cancer. It is currently in Phase 1 clinical development and is designed to target ALK. It is not yet approved for any indication.
NVL-330 targets ALK, a gene that encodes a receptor tyrosine kinase. Dysregulated ALK signaling drives tumor growth in certain cancers. By targeting ALK, NVL-330 aims to inhibit this signaling pathway in patients whose tumors harbor ALK alterations.
NVL-330 is being developed by Nuvalent, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker NUVL. Nuvalent is the sponsor responsible for the clinical development of NVL-330.
NVL-330 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The Phase 1 program is currently recruiting participants and is designed to evaluate the drug in patients with advanced solid tumors.
NVL-330 is being studied in one active clinical trial, NCT06521554, titled HEROEX-1. This Phase 1 study is recruiting approximately 200 patients with advanced or metastatic HER2-altered non-small cell lung cancer and other locally advanced or metastatic solid tumors across the United States, Australia, and Canada.
The Phase 1 HEROEX-1 trial (NCT06521554) enrolls adults aged 18 years and older of any sex. It does not include healthy volunteers. Participants must have locally advanced or metastatic solid tumors, with biomarker selection based on HER2 alteration status.