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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Mar 2026 to Jan 2027 Enrollment target: 150 to 200 · Completion date: Mar 2026 to Feb 2027 · Eligibility criteria revised · 3 morev13 Show 6 more changesShow less
    • Enrollment target: 150 to 200
    • Completion date: Mar 2026 to Feb 2027
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 4 of 25 entries
    • Study description revised
    • Site contacts updated at 1 of 21 sites

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv12
  3. Study sites: 19 to 21v11
  4. Study sites: 17 to 19v10
  5. Enrollment target: 120 to 150v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 16 to 17v8
  2. Study sites: 13 to 16v7
  3. Study sites: 12 to 13v6
  4. Study sites: 11 to 12v5
  5. Study sites: 10 to 11v4
  6. Study sites: 7 to 10v3
  7. Study sites: 4 to 7v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06521554
Lead Sponsor Nuvalent Inc.
Conditions Locally Advanced Solid Tumor, Metastatic Solid Tumor
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov