A Phase Ia/Ib Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Patients With Locally Advanced Or Metastatic ER-Positive, HER2-Negative Breast Cancer Who Have Previously Progressed During or After CDK4/6 Inhibitor Therapy
Genentech, Inc.
Summary
This is a first-in-human, Phase Ia/Ib, dose-escalation and expansion study evaluating the safety, pharmacokinetics, and activity of GDC-0587 (cyclin-dependent kinase-4 \[CDK4\] inhibitor) as a monotherapy and in combination with giredestrant in participants with locally advanced or metastatic estrogen receptor-positive and human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer who have previously progressed during or after CDK 4/6 inhibitor therapy.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Agreement to adhere to the contraception requirements * For females of childbearing potential ≤60 years of age and males: treatment with luteinizing hormone-releasing hormone (LHRH) agonist therapy beginning at least 2 weeks prior to Cycle 1, Day 1 and agreement to continue LHRH agonist therapy for the duration of the study * Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic * Previously documented ER+ and HER2- tumor according to American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CA…
Interventions
- DrugGDC-0587
Participants will receive GDC-0587 orally as per the schedule in the protocol.
- DrugGiredestrant
Participants will receive Giredestrant orally as per the schedule in the protocol.
- DrugOmeprazole
Participants will receive Omeprazole orally as per the schedule in the protocol.
Locations (4)
- START - Midwest - EDOSGrand Rapids, Michigan
- START - San Antonio - EDOSSan Antonio, Texas
- National Taiwan University HospitalTaipei, Taipei City
- National Cheng Kung University HospitalTainan