Status:
RECRUITING
A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)
Lead Sponsor:
Nuvalent Inc.
Conditions:
Locally Advanced Solid Tumor
Metastatic Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 patie...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06521554
Start Date
July 18 2024
End Date
March 1 2026
Last Update
September 16 2025
Active Locations (21)
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1
City of Hope - Lennar
Irvine, California, United States, 92618
2
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
3
Stanford Cancer Institute
Stanford, California, United States, 94305
4
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218