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

Part of paid clinical trials in Grand Rapids, Michigan.

Sponsor
Genentech, Inc.
Study ID
NCT07214662
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GDC-0587 — DRUG
    Participants will receive GDC-0587 orally as per the schedule in the protocol.
  • Giredestrant — DRUG
    Participants will receive Giredestrant orally as per the schedule in the protocol.
  • Omeprazole — DRUG
    Participants will receive Omeprazole orally as per the schedule in the protocol.

Study Details

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.

Key Dates

Start date
Jan 13, 2026
Status verified
Jun 2026
Primary completion
Jun 1, 2030
Completion
Jun 1, 2030

Study Design

Enrollment
136 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase Ia: GDC-0587 Monotherapy
    Participants will receive GDC-0587 orally.
  • Experimental: Phase Ib: GDC-0587 + Giredestrant Cohort
    Participants will receive GDC-0587 and Giredestrant orally.
  • Experimental: Phase Ib: GDC-0587 + Giredestrant Food-Effect and PPI-Effect Cohort
    Participants will receive GDC-0587 and Giredestrant orally and also receive omeprazole for evaluating the effects of a proton pump inhibitor (PPI) and food on GDC-0587.

Primary Outcome Measure

Percentage of Participants with Adverse Events [ Time Frame: From Baseline to 30 days after final dose of study treatment (Up to approximately to 18 months) ]

Central Contacts

  • Reference Study ID Number: GO46057 https://forpatients.roche.com/
    888-662-6728 (U.S. only)
    [email protected]
  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (2)

FacilityCityStateZIPSite coordinators
START - Midwest - EDOSGrand RapidsMichigan49546-7062-
START - San Antonio - EDOSSan AntonioTexas78229-3307-

Find similar trials in Grand Rapids, MI

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
START - Midwest - EDOS· Grand Rapids, MISTART - San Antonio - EDOS· San Antonio, TX

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