A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNuvalent Inc.
About this trial
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 criteria
Qualifiers
Age ≥ 18 years
Histologically or cytologically confirmed locally advanced or metastatic NSCLC
Phase 1a: Documented oncogenic HER2 mutation such as HER2 exon20 insertion mutations or single nucleotide variants or HER2 amplification.
Phase 1b: Documented oncogenic HER2 mutation.
Disqualifiers
Participant's cancer has known oncogenic driver alteration other than HER2
Known allergy/hypersensitivity to excipients of NVL-330
Major surgery within 4 weeks of the first dose of study drug
Ongoing or recent anticancer therapy
Trial design
Treatments tested in this trial
- NVL-330
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov