A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)

Recruiting now · Phase 1

Conditions studied: Locally Advanced Solid Tumor, Metastatic Solid Tumor

In brief

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 1b expansion is designed to further evaluate the overall safety and tolerability of the candidate RP2D(s) of NVL-330 and to determine the RP2D of NVL-330 in participants with advanced or metastatic HER2 mutant NSCLC.

Key facts

Study ID

NCT06521554

Run by

Nuvalent Inc.

People needed

200

Starts

2024-07-18

Expected to finish

2027-02-01

Last updated by the study team

2026-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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.
• 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

You may not qualify 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

Where it is running

• City of Hope - Lennar — Irvine, California, United States (enrolling)
• University of California, Davis Comprehensive Cancer Center — Sacramento, California, United States (enrolling)
• Stanford Cancer Institute — Stanford, California, United States (enrolling)
• Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States (enrolling)
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States (enrolling)
• Sibley Memorial Hospital — Washington D.C., District of Columbia, United States (enrolling)
• Sylvester Comprehensive Cancer Center — Miami, Florida, United States (enrolling)
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Henry Ford Cancer Center — Detroit, Michigan, United States (enrolling)
• Washington University — St Louis, Missouri, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• OSU Brain and Spine Hospital — Columbus, Ohio, United States (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• NEXT Virginia — Fairfax, Virginia, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
• Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia (enrolling)
• North Shore Health Hub — Saint Leonards, New South Wales, Australia (enrolling)
• Cross Cancer Institute — Edmonton, Alberta, Canada (enrolling)
• Princess Margaret Cancer Center - University Health Network — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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