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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

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenentech, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

136 Participants
are divided into 3 treatment groups
Group A: Phase Ia: GDC-0587 MonotherapyExperimental treatment 1 intervention
Group B: Phase Ib: GDC-0587 + Giredestrant CohortExperimental treatment 2 interventions
Group C: Phase Ib: GDC-0587 + Giredestrant Food-Effect and PPI-Effect CohortExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Percentage of Participants with Adverse Events

Measured by reporting the incidence and severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 grading scale.

Time frame
From Baseline to 30 days after final dose of study treatment (Up to approximately to 18 months)
2

Percentage of Participants with Dose-limiting Toxicity (DLTs)

Time frame
Phase 1a: Days 1-28 of Cycle 1; Phase 1b: Days 1-28 of Cycle 1 (Each cycle is 28 days)

Secondary outcomes

1

Percentage of Participants With Objective Response Rate (ORR) of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Time frame
Up to approximately to 18 months
2

Plasma Concentration of GDC-0587 as a Monotherapy and in Combination With Giredestrant

Time frame
Phase 1a: Cycle 1 (Day 1, 2 15, 16), Cycle 2, 3, 5, 7, 9, 11 (Day 1); Phase 1b: Cycle 1 (Day 1, 2 15, 16), Cycle 2, 3, 5, 7, 9, 11 (Day 1) (Each cycle is 28 days)
3

Plasma Concentration of GDC-0587 with Giredestrant Under Fasted and Fed Conditions

Time frame
Part 1b: Cycle 1 (Day 1, 2, 4), Cycle 2, 3, 5, 7, 9 and 11 (Day 1) (Each cycle is 28 days)
4

Plasma Concentration of GDC-0587 with Giredestrant Following Multiple-dose Administration, Either Alone or in Combination With Omeprazole

Time frame
Part 1b: Cycle 1 (Day 11, 12, 20 and 21) (Each cycle is 28 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genentech, Inc.

Lead sponsor

Source ClinicalTrials.gov
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