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

Study Identifier:
GO46057
CT.gov Identifier:
NCT07214662
EudraCT Identifier:
202552000000
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
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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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Breast Cancers
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: EXPERIMENTAL: Phase Ia: GDC-0587 Monotherapy
    • Read More
  • Drug: Participants will receive GDC-0587 orally.
  • Drug: Drug: GDC-0587
  • Drug: Participants will receive GDC-0587 orally as per the schedule in the protocol.
  • Drug: Other Names: RO7840736, RGT-587
  • Drug: EXPERIMENTAL: Phase Ib: GDC-0587 + Giredestrant Cohort
  • Drug: Participants will receive GDC-0587 and Giredestrant orally.
  • Drug: Drug: Giredestrant
  • Drug: Participants will receive Giredestrant orally as per the schedule in the protocol.
  • Drug: Other Names: GDC-9545, RO7197597, RG6171
  • Drug: EXPERIMENTAL: Phase Ib: GDC-0587 + Giredestrant Food-Effect and PPI-Effect Cohort
  • Drug: 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.
  • Drug: Drug: Omeprazole
  • Drug: Participants will receive Omeprazole orally as per the schedule in the protocol.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Muralidhar Beeram
    Status
    Recruiting
    Condition(s) Treated at Site
    Breast Cancers
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Manish Sharma
    Status
    Recruiting
    Condition(s) Treated at Site
    Breast Cancers