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

Part of paid clinical trials in Irvine, California.

Sponsor
Nuvalent Inc.
Study ID
NCT06521554
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Locally Advanced Solid Tumor
  • Metastatic Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NVL-330 — DRUG
    Oral Tablet of NVL-330

Study Details

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.

Key Dates

Start date
Jul 18, 2024
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a dose escalation
    NVL-330 oral daily dosing
  • Experimental: Phase 1b dose expansion
    NVL-330 oral daily dosing

Primary Outcome Measure

Recommended Phase 2 Dose (RP2D) [ Time Frame: As determined by incidence of DLTs during the first 28 days of treatment (ie, Cycle 1) ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
City of Hope - LennarIrvineCalifornia92618
Danny Nguyen, MD (PRINCIPAL_INVESTIGATOR)
University of California, Davis Comprehensive Cancer CenterSacramentoCalifornia95817
Jonathan Riess, MD (PRINCIPAL_INVESTIGATOR)
Stanford Cancer InstituteStanfordCalifornia94305
Joel Neal, MD PhD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research Institute at HealthONEDenverColorado80218
Gerald Falchook, MD MS (PRINCIPAL_INVESTIGATOR)
Georgetown University Medical CenterWashington D.C.District of Columbia20007
Joshua Reuss, MD (PRINCIPAL_INVESTIGATOR)
Sibley Memorial HospitalWashington D.C.District of Columbia20016
Susan Scott, MD (PRINCIPAL_INVESTIGATOR)
Sylvester Comprehensive Cancer CenterMiamiFlorida33136
Gilberto de Lima Lopes, Jr., MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Bayview Medical CenterBaltimoreMaryland21224
Susan Scott, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Zofia Piotrowska, MD MHS (PRINCIPAL_INVESTIGATOR)
Henry Ford Cancer CenterDetroitMichigan48242
Shirish Gadgeel, MD (PRINCIPAL_INVESTIGATOR)
Washington UniversitySt LouisMissouri63110
Maria Baggstrom, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Fernando Santini, MD (PRINCIPAL_INVESTIGATOR)
OSU Brain and Spine HospitalColumbusOhio43210
Dwight Owen, MD (PRINCIPAL_INVESTIGATOR)
SCRI Oncology PartnersNashvilleTennessee37203
Melissa Johnson, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Haniel Araujo, MD (PRINCIPAL_INVESTIGATOR)
NEXT VirginiaFairfaxVirginia22031
Alexander Spira, MD PhD FACP (PRINCIPAL_INVESTIGATOR)
Fred Hutchinson Cancer CenterSeattleWashington98109
Rebecca Wood
206-606-6970
Christina Baik, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Irvine, CA

By research site
City of Hope - Lennar· Irvine, CAUniversity of California, Davis Comprehensive Cancer Center· Sacramento, CAStanford Cancer Institute· Stanford, CASarah Cannon Research Institute at HealthONE· Denver, COGeorgetown University Medical Center· Washington D.C., DCSibley Memorial Hospital· Washington D.C., DC

Related Studies