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
New breast cancer drug GDC-0587 tested in early-stage trial
Plain English Summary
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 is a Phase 1 clinical trial sponsored by Genentech, Inc. studying Breast Cancer. This trial tests a new drug called GDC-0587, alone and with another drug called giredestrant. It is for patients with advanced or spreading ER-positive, HER2-negative breast cancer that has not responded to CDK4/6 inhibitor treatments. Participants will take study drugs by mouth and will have regular check-ups and tests. Standard treatments for this type of breast cancer include other hormone therapies and chemotherapy. The trial aims to enroll 136 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with ER-positive, HER2-negative breast cancer that has spread or cannot be removed by surgery. Must have previously been treated with a CDK4/6 inhibitor drug and their cancer has worsened. Patients must be between 18 and 60 years old if female and of childbearing potential, and using specific birth control methods. Cannot have untreated brain metastases or severe organ problems. This trial is studying Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcomes measure how safe the drugs are and if they cause any serious side effects, which helps determine the right dose for future studies. The specific primary outcome measures are: Percentage of Participants with Adverse Events (From Baseline to 30 days after final dose of study treatment (Up to approximately to 18 months)); Percentage of Participants with Dose-limiting Toxicity (DLTs) (Phase 1a: Days 1-28 of Cycle 1; Phase 1b: Days 1-28 of Cycle 1 (Each cycle is 28 days)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.
Why This Trial Matters
This trial addresses a critical need for new treatments for patients with advanced ER+/HER2- breast cancer whose disease has progressed after standard CDK4/6 inhibitor therapy. This research targets Breast Cancer, where improved treatment options are needed.
Investor Insight
This trial targets a significant market of breast cancer patients who have exhausted current treatment options, with potential for a new combination therapy if successful. Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about the study drugs, potential side effects, and how often you will need to visit the clinic. Participation involves taking oral medications and undergoing regular blood tests, scans, and physical exams. Be prepared for potential side effects and discuss any concerns with your healthcare team immediately. This trial is currently recruiting participants. The trial is being conducted at 3 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: SEQUENTIAL
- Masking: NONE
- Enrollment: 136 participants
Interventions
- DRUG: GDC-0587 — Participants will receive GDC-0587 orally as per the schedule in the protocol.
- DRUG: Giredestrant — Participants will receive Giredestrant orally as per the schedule in the protocol.
- DRUG: Omeprazole — Participants will receive Omeprazole orally as per the schedule in the protocol.
Primary Outcomes
- Percentage of Participants with Adverse Events (From Baseline to 30 days after final dose of study treatment (Up to approximately to 18 months))
- Percentage of Participants with Dose-limiting Toxicity (DLTs) (Phase 1a: Days 1-28 of Cycle 1; Phase 1b: Days 1-28 of Cycle 1 (Each cycle is 28 days))
Secondary Outcomes
- 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) (Up to approximately to 18 months)
- Plasma Concentration of GDC-0587 as a Monotherapy and in Combination With Giredestrant (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))
- Plasma Concentration of GDC-0587 with Giredestrant Under Fasted and Fed Conditions (Part 1b: Cycle 1 (Day 1, 2, 4), Cycle 2, 3, 5, 7, 9 and 11 (Day 1) (Each cycle is 28 days))
- Plasma Concentration of GDC-0587 with Giredestrant Following Multiple-dose Administration, Either Alone or in Combination With Omeprazole (Part 1b: Cycle 1 (Day 11, 12, 20 and 21) (Each cycle is 28 days))
- Recommended Phase II Dose (RP2D) of GDC-0587 (Up to approximately to 18 months)
Full Eligibility 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
Trial Locations
- START - Midwest - EDOS, Grand Rapids, Michigan, United States
- START - San Antonio - EDOS, San Antonio, Texas, United States
- National Cheng Kung University Hospital, Tainan, Taiwan
Frequently Asked Questions
What is clinical trial NCT07214662?
NCT07214662 is a Phase 1 INTERVENTIONAL 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." It is currently recruiting and is sponsored by Genentech, Inc.. The trial targets enrollment of 136 participants.
What conditions does NCT07214662 study?
This trial investigates treatments for Breast Cancer. The primary condition under study is Breast Cancer.
What treatments are being tested in NCT07214662?
The interventions being studied include: GDC-0587 (DRUG), Giredestrant (DRUG), Omeprazole (DRUG). Participants will receive GDC-0587 orally as per the schedule in the protocol.
What does Phase 1 mean for NCT07214662?
Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.
What is the current status of NCT07214662?
This trial is currently "Recruiting." It started on 2026-01-13. The estimated completion date is 2030-04-01.
Who is sponsoring NCT07214662?
NCT07214662 is sponsored by Genentech, Inc.. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07214662?
The trial aims to enroll 136 participants. The trial is currently recruiting and accepting new participants.
How is NCT07214662 designed?
This is a interventional study, uses non_randomized allocation, follows a sequential design, employs none masking.
What are the primary outcomes being measured in NCT07214662?
The primary outcome measures are: Percentage of Participants with Adverse Events (From Baseline to 30 days after final dose of study treatment (Up to approximately to 18 months)); Percentage of Participants with Dose-limiting Toxicity (DLTs) (Phase 1a: Days 1-28 of Cycle 1; Phase 1b: Days 1-28 of Cycle 1 (Each cycle is 28 days)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07214662 being conducted?
This trial is being conducted at 3 sites, including Grand Rapids, Michigan; San Antonio, Texas; Tainan (United States, Taiwan).
Where can I find official information about NCT07214662?
The official record for NCT07214662 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07214662. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07214662 testing in simple terms?
This trial tests a new drug called GDC-0587, alone and with another drug called giredestrant. It is for patients with advanced or spreading ER-positive, HER2-negative breast cancer that has not responded to CDK4/6 inhibitor treatments.
Why is this trial significant?
This trial addresses a critical need for new treatments for patients with advanced ER+/HER2- breast cancer whose disease has progressed after standard CDK4/6 inhibitor therapy.
What are the potential risks of participating in NCT07214662?
Common side effects may include fatigue, nausea, diarrhea, and changes in blood counts. Serious side effects, though rare, can include severe allergic reactions or organ damage. The study will monitor for dose-limiting toxicities, which are severe side effects that may require stopping the study drug. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07214662?
Ask your doctor about the study drugs, potential side effects, and how often you will need to visit the clinic. Participation involves taking oral medications and undergoing regular blood tests, scans, and physical exams. Be prepared for potential side effects and discuss any concerns with your healthcare team immediately. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07214662 signal from an investment perspective?
This trial targets a significant market of breast cancer patients who have exhausted current treatment options, with potential for a new combination therapy if successful. This is a Phase 1 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will take study drugs by mouth and will have regular check-ups and tests. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.