A Phase 1a/1b Study of the Selective Tyrosine Kinase Inhibitor NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
City of Hope - Lennar
RECRUITING
Irvine
University of California, Davis Comprehensive Cancer Center
RECRUITING
Sacramento
Stanford Cancer Institute
RECRUITING
Stanford
Colorado
Sarah Cannon Research Institute at HealthONE
RECRUITING
Denver
Washington, D.c.
Georgetown University Medical Center
RECRUITING
Washington D.c.
Sibley Memorial Hospital
RECRUITING
Washington D.c.
Florida
Sylvester Comprehensive Cancer Center
RECRUITING
Miami
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Bayview Medical Center
RECRUITING
Baltimore
Michigan
Henry Ford Cancer Center
RECRUITING
Detroit
Missouri
Washington University
RECRUITING
St Louis
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Ohio
OSU Brain and Spine Hospital
RECRUITING
Columbus
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Texas
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Virginia
NEXT Virginia
RECRUITING
Fairfax
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Other Locations
Australia
Chris O'Brien Lifehouse
RECRUITING
Camperdown
North Shore Health Hub
RECRUITING
Saint Leonards
Canada
Cross Cancer Institute
RECRUITING
Edmonton
Princess Margaret Cancer Center - University Health Network