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NCT07214662 · ClinicalTrials.gov registry record · Phase 1

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 1 study of Breast Cancer, sponsored by Genentech.

Recruiting
Registry status
Phase 1
Development phase
136
Enrollment target
3
Study locations

NCT07214662 is a Phase 1 study of Breast Cancer that is actively recruiting participants, run by Genentech. The registered enrollment target is 136 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT07214662, a Phase 1 study of Breast Cancer, is actively recruiting participants, sponsored by Genentech.

RECRUITING
Registry status
Phase 1
Development phase
136 participants
Enrollment target
3
Study locations

Study 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.

Conditions Studied

Breast Cancer

Interventions

  • DRUG Omeprazole
  • DRUG Giredestrant
  • DRUG GDC-0587

Study Locations (3)

Michigan

  • START - Midwest - EDOS - Grand Rapids

Texas

  • START - San Antonio - EDOS - San Antonio

Other

  • National Cheng Kung University Hospital - Tainan

Trial Details

FieldValue
Enrollment Target 136 participants
Start Date 2026-01-13
Est. Completion 2030-04-01
Phase Phase 1

Sponsor

Genentech

332 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07214662

The ClinicalTrials.gov registry entry for NCT07214662 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Omeprazole is the first listed.

NCT07214662 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Michigan, Texas, Other.

Frequently Asked Questions

What is clinical trial NCT07214662 about?

NCT07214662 is a clinical study titled "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". 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 estrog...

What is the current status of trial NCT07214662?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 136 participants. The study started on 2026-01-13. Estimated completion is 2030-04-01.

What conditions does trial NCT07214662 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT07214662?

The interventions under investigation include: Omeprazole (DRUG), Giredestrant (DRUG), GDC-0587 (DRUG).

Who is sponsoring clinical trial NCT07214662?

This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07214662 being conducted?

This trial has 3 study locations across Michigan, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.