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

Description

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.

Conditions

Locally Advanced Solid Tumor, Metastatic Solid Tumor

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Study Overview

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Study Details

Study overview

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.

A Phase 1a/1b Study of the Selective Tyrosine Kinase Inhibitor NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)

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

Condition
Locally Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Stanford

Stanford Cancer Institute, Stanford, California, United States, 94305

Denver

Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States, 80218

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Detroit

Henry Ford Cancer Center, Detroit, Michigan, United States, 48242

Saint Louis

Washington University, Saint Louis, Missouri, United States, 63110

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Nashville

SCRI Oncology Partners, Nashville, Tennessee, United States, 37203

Houston

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

Fairfax

NEXT Virginia, Fairfax, Virginia, United States, 22031

Seattle

Fred Hutchinson Cancer Center, Seattle, Washington, United States, 98109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Nuvalent Inc.,

Vivek Upadhyay, MD, STUDY_DIRECTOR, Nuvalent Inc.

Study Record Dates

2026-03