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A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)
Sponsor: Nuvalent Inc.
Summary
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.
Official title: A Phase 1a/1b Study of the Selective Tyrosine Kinase Inhibitor NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2024-07-18
Completion Date
2027-02
Last Updated
2026-02-25
Healthy Volunteers
No
Interventions
NVL-330
Oral Tablet of NVL-330
Locations (21)
City of Hope - Lennar
Irvine, California, United States
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States
Stanford Cancer Institute
Stanford, California, United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Cancer Center
Detroit, Michigan, United States
Washington University
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
OSU Brain and Spine Hospital
Columbus, Ohio, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
NEXT Virginia
Fairfax, Virginia, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
North Shore Health Hub
Saint Leonards, New South Wales, Australia
Cross Cancer Institute
Edmonton, Alberta, Canada
Princess Margaret Cancer Center - University Health Network
Toronto, Ontario, Canada