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Trial Title:
A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)
NCT ID:
NCT06521554
Condition:
Locally Advanced Solid Tumor
Metastatic Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
NVL-330
Description:
Oral Tablet of NVL-330
Arm group label:
Phase 1a dose escalation
Arm group label:
Phase 1b dose expansion
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 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.
Detailed description:
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
to confirm the RP2D(s).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years
2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC
3. Documented HER2 status as follows:
1. Phase 1a: Documented oncogenic HER2 mutation such as HER2 exon20 insertion
mutations or single nucleotide variants or HER2 amplification.
2. Phase 1b: Documented oncogenic HER2 mutation.
4. Identification of lesions as follows:
1. Phase 1a: Must have evaluable disease (target or nontarget) according to RECIST
1.1.
2. Phase 1b: Must have measurable disease, defined as ≥ 1 radiologically
measurable target lesion according to RECIST 1.1.
5. Adequate organ function and bone marrow reserve
Exclusion Criteria:
1. Patient's cancer has known oncogenic driver alteration other than HER2
2. Known allergy/hypersensitivity to excipients of NVL-330
3. Major surgery within 4 weeks of the first dose of study drug
4. Ongoing or recent anticancer therapy
5. Actively receiving systemic treatment or direct medical intervention on another
therapeutic clinical study
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Stanford Cancer Institute
Address:
City:
Stanford
Zip:
94305
Country:
United States
Status:
Recruiting
Facility:
Name:
Sarah Cannon Research Institute at HealthONE
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Zofia Piotrowska, MD
Facility:
Name:
Henry Ford Cancer Center
Address:
City:
Detroit
Zip:
48242
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shirish Gadgeel, MD
Facility:
Name:
Washington University
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Maria Baggstrom, MD
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
SCRI Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
NEXT Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Start date:
July 18, 2024
Completion date:
March 2026
Lead sponsor:
Agency:
Nuvalent Inc.
Agency class:
Industry
Source:
Nuvalent Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06521554
