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

2026-02-25

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

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)

Facility	City	Region	Status
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	Recruiting
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

A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1) Recruiting

Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC Recruiting

Other trials for the same condition

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE) Recruiting

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

A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors Recruiting

A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors Recruiting

A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1) 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