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New treatment option for Locally Advanced Solid Tumor
Official title A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)
ClinicalTrials.gov ID: NCT06521554
What this study is testing
What is NVL-330?
NVL-330 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for locally advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Phase 1a/1b dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-330, determine the recommended Phase 2 dose (RP2D), and evaluate the antitumor activity in participants with advanced or metastatic human epidermal growth factor receptor 2 (HER2) -altered non-small lung cancer (NSCLC). Phase 1a dose escalation is designed to assess the safety and tolerability of NVL-330 and to select the candidate RP2D(s) and, if applicable, the MTD.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC
- Documented HER2 status as follows:
- Phase 1a: Documented oncogenic HER2 mutation such as HER2 exon20 insertion mutations or single nucleotide variants or HER2 amplification.
- Phase 1b: Documented oncogenic HER2 mutation.
You likely can't join if
- Participant's cancer has known oncogenic driver alteration other than HER2
- Known allergy/hypersensitivity to excipients of NVL-330
- Major surgery within 4 weeks of the first dose of study drug
- Ongoing or recent anticancer therapy
- Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study
See the full eligibility criteria
- Age ≥ 18 years
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC
- Documented HER2 status as follows:
- Phase 1a: Documented oncogenic HER2 mutation such as HER2 exon20 insertion mutations or single nucleotide variants or HER2 amplification.
- Phase 1b: Documented oncogenic HER2 mutation.
- Identification of lesions as follows:
- Phase 1a: Must have evaluable disease (target or nontarget) according to RECIST 1.1.
- Phase 1b: Must have measurable disease, defined as ≥ 1 radiologically measurable target lesion according to RECIST 1.1.
- Adequate organ function and bone marrow reserve
- Participant's cancer has known oncogenic driver alteration other than HER2
- Known allergy/hypersensitivity to excipients of NVL-330
- Major surgery within 4 weeks of the first dose of study drug
- Ongoing or recent anticancer therapy
- Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
- Sacramento, California, United States
- Stanford, California, United States
- Denver, Colorado, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
- Seattle, Washington, United States
- Camperdown, New South Wales, Australia
- Saint Leonards, New South Wales, Australia
- Edmonton, Alberta, Canada
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States; Sacramento, California, United States; Stanford, California, United States; Denver, Colorado, United States; Washington D.C., District of Columbia, United States; Miami, Florida, United States and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.