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NCT07214662 | RECRUITING | Breast Cancer

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
Sponsor:

Genentech, Inc.

Brief 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.

Condition or disease

Breast Cancer

Intervention/treatment

GDC-0587

Giredestrant

Omeprazole

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 136 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2026-01-13
Estimated Primary Completion Date : 2030-04-01
Estimated Study Completion Date : 2030-04-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Agreement to adhere to the contraception requirements
  • * For females of childbearing potential ≤60 years of age and males: treatment with luteinizing hormone-releasing hormone (LHRH) agonist therapy beginning at least 2 weeks prior to Cycle 1, Day 1 and agreement to continue LHRH agonist therapy for the duration of the study
  • * Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic
  • * Previously documented ER+ and HER2- tumor according to American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) or European Society of Medical Oncology (ESMO) guidelines or any national guidelines with criteria conforming to ASCO/CAP or ESMO guidelines
  • * Disease progression during or following treatment with an approved CDK 4/6 inhibitor, with or without endocrine therapy, in the locally advanced or metastatic setting
  • * Measurable, or non-measurable but evaluable, disease per RECIST v1.1
  • * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • * Life expectancy ≥6 months
  • * Creatinine clearance ≥60 milliliter per minute (mL/min) (calculated through use of the Cockcroft-Gault formula)
Exclusion Criteria
  • * Pregnant or breastfeeding, or intention of becoming pregnant during the study
  • * Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines
  • * Five or more prior lines of systemic therapy in the locally advanced or metastatic setting
  • * Treatment with anti-cancer therapies, including investigational therapies, within 28 days or 5 drug elimination half-lives, whichever is shorter, prior to initiation of study drug
  • * Treatment with an approved oral endocrine therapy within 7 days prior to initiation of study drug or treatment with fulvestrant or an approved/investigational CDK inhibitor within 21 days prior to initiation of study drug
  • * History of Grade ≥3 adverse event attributed to prior CDK inhibitor therapy that resulted in permanent discontinuation of prior CDK inhibitor therapy
  • * Poor peripheral venous access
  • * Malabsorption condition or other gastrointestinal (GI) conditions/surgeries that the investigator assesses may significantly interfere with enteral absorption
  • * Major surgical procedure within 28 days prior to initiation of study drug
  • * Untreated, active CNS metastases
  • * Infection requiring systemic (i.e., oral, IV, or intramuscular) antibiotics, chronic infection requiring treatment within 1 year prior to screening, or any evidence of current infection
  • * History of malignancy within 3 years prior to screening, except for cancer under investigation in this study
  • * Known history of a clinically significant abnormal ECG
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

Location Details

NCT07214662

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Locations

RECRUITING

United States, road cancer

START - Midwest - EDOS

Grand Rapids, road cancer, United States, 49546-7062

RECRUITING

United States, Texas

START - San Antonio - EDOS

Saint Anthony, Texas, United States, 78229-3307

RECRUITING

Taiwan,

National Cheng Kung University Hospital

I think, Taiwan, 70403