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

First listed
Oct 9, 2025
Start date
Jan 13, 2026
Status verified
Jul 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/ No attachments to email below.
    888-662-6728 (U.S. only)
    [email protected]
  • Fastest response: use the inquiry form. 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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