RecruitingPhase 1NCT07214662

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

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


Sponsor

Genentech, Inc.

Enrollment

136 participants

Start Date

Jan 13, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug combination — GDC-0587 with or without giredestrant — for people with advanced estrogen receptor-positive, HER2-negative (ER+/HER2-) breast cancer that has progressed after CDK 4/6 inhibitor treatment (a common class of targeted therapy). **You may be eligible if...** - You have advanced or metastatic ER+/HER2- breast cancer confirmed by biopsy - Your cancer progressed during or after treatment with a CDK 4/6 inhibitor - You are reasonably functional (ECOG 0 or 1) with at least 6 months life expectancy - Your kidney function is adequate (creatinine clearance at least 60 mL/min) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have had 5 or more prior treatment regimens for advanced/metastatic disease - You have untreated active brain metastases - You have had major surgery, serious infections, or certain prior cancer treatments within the past 4 weeks - You have a history of grade 3 or higher side effects from prior CDK inhibitor therapy that caused permanent discontinuation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 - EDOS

Grand Rapids, Michigan, United States

START - San Antonio - EDOS

San Antonio, Texas, United States

National Taiwan University Hospital

Taipei, Taipei City, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

View Full Details on ClinicalTrials.gov

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NCT07214662


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