Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC
Status:
Not yet recruiting
Trial end date:
2026-09-01
Target enrollment:
Participant gender:
Summary
NUV-422-03 is a randomized, non-comparative Phase 1/2 dose escalation and expansion study
designed to evaluate the safety and efficacy of NUV-422 in combination with fulvestrant
relative to NUV-422 monotherapy and fulvestrant monotherapy. The study population is
comprised of adults with HR+HER2- aBC. Patients will self-administer NUV-422 orally in 28-day
cycles and receive 500 mg fulvestrant intramuscularly (IM) on Days 1 and 15 of Cycle 1 and
Day 1 of every cycle thereafter. Patients will be treated until disease progression,
toxicity, withdrawal of consent, or termination of the study.