GDC-0587
DrugParticipants will receive GDC-0587 orally as per the schedule in the protocol.
Other names: RO7840736, RGT-587
NCT Number: NCT07214662
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
National Taiwan University Hospital, Taipei, Taipei City, Taiwan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive GDC-0587 orally as per the schedule in the protocol.
Other names: RO7840736, RGT-587
Participants will receive Giredestrant orally as per the schedule in the protocol.
Other names: GDC-9545, RO7197597, RG6171
Participants will receive Omeprazole orally as per the schedule in the protocol.
Time frame: From Baseline to 30 days after final dose of study treatment (Up to approximately to 18 months)
Measured by reporting the incidence and severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 grading scale.
Time frame: Phase 1a: Days 1-28 of Cycle 1; Phase 1b: Days 1-28 of Cycle 1 (Each cycle is 28 days)
Time frame: Up to approximately to 18 months
Time frame: Phase 1a: Cycle 1 (Day 1, 2 15, 16), Cycle 2, 3, 5, 7, 9, 11 (Day 1); Phase 1b: Cycle 1 (Day 1, 2 15, 16), Cycle 2, 3, 5, 7, 9, 11 (Day 1) (Each cycle is 28 days)
Time frame: Part 1b: Cycle 1 (Day 1, 2, 4), Cycle 2, 3, 5, 7, 9 and 11 (Day 1) (Each cycle is 28 days)
Time frame: Part 1b: Cycle 1 (Day 11, 12, 20 and 21) (Each cycle is 28 days)
Time frame: Up to approximately to 18 months
Time frame: Up to approximately to 18 months
Genentech, Inc.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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