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A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)
Trial Status: active
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 patients with advanced or metastatic HER2-altered 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 patients with
advanced or metastatic HER2 mutant NSCLC.
Inclusion 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
Exclusion Criteria
Patient'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
Additional locations may be listed on ClinicalTrials.gov for NCT06521554.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Name Not Available
Sacramento
University of California Davis Comprehensive Cancer Center
Status: Active
Name Not Available
District of Columbia
Washington
MedStar Georgetown University Hospital
Status: Active
Name Not Available
Florida
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Name Not Available
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not Available
Massachusetts
Boston
Massachusetts General Hospital Cancer Center
Status: Active
Name Not Available
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
Ohio
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Status: Active
Name Not Available
The planned Phase 1a/1b first-in-human study is designed as a two-part clinical trial to
investigate NVL-330 in pre-treated patients with advanced or metastatic HER2-altered
NSCLC. The dose escalation phase of the trial is designed to enroll a set number of
patients per cohort at protocol defined dose levels.
After the initial patients are treated at a given dose level and monitored for at least
28 days, available data will be reviewed, and initiation of the next dosing group will
proceed with consideration given to the overall safety profile.
The expansion phase of the trial is designed to further evaluate safety and activity and
