drugset
drugset / Trial / NCT06521554

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

NCT06521554 ↗

Phase 1 Recruiting 200 enrolled Nuvalent Inc.
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2024-07-18
Primary completion
2027-01
Completion
2027-02

Drugs

EvaluationDrugModalityDoseRoute
Subject NVL-330 Unknown — Oral

Indications

metastatic neoplasm