At a glance
ClinicalIndex Comparison RecordPhase 1Active· 6 enrolled
Drug / intervention
vepdegestrantdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A PHASE I, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF ARV-471 (PF-07850327), A SINGLE AGENT IN JAPANESE PARTICIPANTS WITH ER+/HER2-LOCALLY ADVANCED OR METASTATIC BREAST CANCER
In Brief
A Phase 1 clinical trial evaluating vepdegestrant for Breast Neoplasms. Active but no longer recruiting, targeting 6 participants across 3 sites.
Detailed Summary
The purpose of this clinical trial is to learn about the safety, tolerability, Pharmacokinetics (PK), and preliminary efficacy of ARV-471 as monotherapy in Japanese participants with ER+/HER2- locally advanced or metastatic breast cancer (mBC).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesJapan
CollaboratorsArvinas Estrogen Receptor, Inc.
Timeline
Phase 1ActiveOverdue
2023202420252026
First PostedJul 2022
Enrollment StartAug 2022
Primary CompletionMay 2023
Study CompletionMar 2025
TodayJul 2026
First PostedJul 19, 2022
Enrollment StartAug 16, 2022
Primary CompletionMay 4, 2023
Study CompletionMar 31, 2025
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 4.0 years ago
Interventions
vepdegestrantdrug
ARV-471 will be administered orally QD with food, in continuous dosing over 28-day cycles.