ARV-471

Drug

Drug Profile

ARV-471 (vepdegestrant) is an investigational oral PROTAC estrogen receptor degrader being developed by Arvinas and Pfizer for ER-positive, HER2-negative breast cancer. The program has advanced through phase III testing and has regulatory submissions in progress. It is not yet an approved marketed therapy.

Drug Class
Oral PROTAC estrogen receptor degrader
Approval Status
Investigational; FDA Fast Track designation granted and NDA submitted, but not yet approved
Mechanism of Action
Recruits the ubiquitin-proteasome system to ubiquitinate and degrade estrogen receptor protein
Indications
  • \ER-positive, HER2-negative advanced or metastatic breast cancer\

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Related Clinical Trials

NCT ID Title Status Phase
NCT05732428

A Study to Learn About the Study Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People With ER+/HER2- Advanced Breast Cancer in China

COMPLETED PHASE1
NCT05673889

A Study to Understand the Effect of a Study Medicine Called ARV-471 on Dabigatran Etexilate in Healthy Adults

COMPLETED PHASE1
NCT05654623

A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer

ACTIVE_NOT_RECRUITING PHASE3
NCT05652660

A Study to Understand the Effect of a Study Medicine Called ARV-471 on Rosuvastatin in Healthy Adults

COMPLETED PHASE1
NCT05573555

TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study B)

ACTIVE_NOT_RECRUITING PHASE1/PHASE2
NCT05549505

A Trial Using ARV-471 or Anastrozole in Post-Menopausal Women With Breast Cancer Prior to Surgery

COMPLETED PHASE2
NCT05548127

TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A)

ACTIVE_NOT_RECRUITING PHASE1/PHASE2
NCT04072952

A Phase 1/2 Trial of ARV-471 Alone and in Combination With Palbociclib (IBRANCE®) in Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer

COMPLETED PHASE1/PHASE2
NCT01042379

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

RECRUITING PHASE2