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Clinical Trials in the USA / NCT06521554
Recruiting Phase 1

A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)

NCT06521554 · tracked via the Priya Life Science USA tracker
Sponsor
Nuvalent Inc
Phase
Phase 1
Started
2024-07-18
Last updated
2026-10-20

Condition(s) studied

Locally Advanced Solid TumorMetastatic Solid Tumor

Investigational drug(s) / intervention(s)

NVL-330

NVL-330: Oral Tablet of NVL-330

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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. Participant'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

Primary outcome measure(s)

  • Recommended Phase 2 Dose (RP2D) — As determined by incidence of DLTs during the first 28 days of treatment (ie, Cycle 1)
    To determine up to 2 RP2D Candidates
  • Maximum Tolerated Dose (MTD) — As determined by incidence of DLTs during the first 28 days of treatment (ie, Cycle 1)
    If applicable, to determine the MTD
  • Incidence and severity of Treatment Emergent Adverse Events (TEAEs) — First dose of study drug through 30 days after the last dose of study drug
    Number of participants with TEAEs as assessed by CTCAE, v5.0

Trial sites (21)

FacilityCityRegionStatus
City of Hope - Lennar Irvine California Recruiting
University of California, Davis Comprehensive Cancer Center Sacramento California Recruiting
Stanford Cancer Institute Stanford California Recruiting
Sarah Cannon Research Institute at HealthONE Denver Colorado Recruiting
Georgetown University Medical Center Washington D.C. District of Columbia Recruiting
Sibley Memorial Hospital Washington D.C. District of Columbia Recruiting
Sylvester Comprehensive Cancer Center Miami Florida Recruiting
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Bayview Medical Center Baltimore Maryland Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Henry Ford Cancer Center Detroit Michigan Recruiting
Washington University St Louis Missouri Completed
Memorial Sloan Kettering Cancer Center New York New York Recruiting
OSU Brain and Spine Hospital Columbus Ohio Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas Recruiting
NEXT Virginia Fairfax Virginia Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting
Chris O'Brien Lifehouse Camperdown New South Wales Recruiting
North Shore Health Hub Saint Leonards New South Wales Recruiting
Cross Cancer Institute Edmonton Alberta Recruiting
Princess Margaret Cancer Center - University Health Network Toronto Ontario Recruiting

More Nuvalent Inc. trials in the USA

A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1) Recruiting
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC Recruiting
A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1) Recruiting

Other trials for the same condition

Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors Recruiting
FOG-001 in Locally Advanced or Metastatic Solid Tumors Recruiting
Study of LP-184 in Patients With Advanced Solid Tumors Active, not recruiting
First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors Recruiting
ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06521554 on ClinicalTrials.gov ↗ ← All trials in the USA