Clinical Trial

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 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

Recruiting Phase 1
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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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2030-04-01 -> 2030-06-01 2026-05-05
minor Completion pushed: 2030-04-01 -> 2030-06-01 2026-05-05
Trial Details
NCT Number NCT07214662
Lead Sponsor Genentech, Inc.
Conditions Breast Cancer
Enrollment 136 participants
Start Date 2026-01-13
Primary Completion 2030-06-01 (estimated)
Study Completion 2030-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-05