Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer
Study to Assess the Safety and Efficacy of Evexomostat (SDX-7320) in Combination With A PI3K or Akt Inhibitor Plus Fulvestrant in Patients With HR+, HER2-, Metastatic Breast Cancer With PI3K Pathway Alteration(s)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests evexomostat with fulvestrant and either alpelisib or capivasertib for advanced breast cancer. It is for adult men and women past menopause whose cancer is HR-positive, HER2-negative and has a change in the PI3K pathway, which helps cells grow. Researchers will check safety, whether treatment lowers high blood sugar, and whether it helps control cancer.
This is a Phase 1b/2, open-label, parallel-arms pilot study in men and post-menopausal women with hormone receptor positive (HR+), HER2- advanced or metastatic breast cancer with an alteration in the PI3K pathway, including a mutation of the PIK3CA gene, PTEN loss, or AKT1 mutation, designed to determine the safety of evexomostat (SDX-7320) plus standard of care treatment alpelisib (BYL-719) or capivasertib and fulvestrant (each combined, the 'triplet therapy'), to measure the severity and number of hyperglycemic events, and to assess clinical, anti-tumor benefit of the triplet therapy. The purpose of this study is: * to characterize the safety of the triplet drug combination consisting of either alpelisib or capivasertib (per the treating oncologist's choice) and fulvestrant plus evexomostat, * to test whether evexomostat, when given in combination with either alpelisib or capivasertib and fulvestrant will reduce the number and severity of hyperglycemic events and/or reduce the number or dose of anti-diabetic medications needed to control the hyperglycemia for metabolically normal patients and those deemed at risk for capivasertib and alpelisib-induced hyperglycemia (insulin resistance, as measured by HOMA-IR, baseline elevated HbA1c or well-controlled type 2 diabetes), and * to assess preliminary anti-tumor efficacy for each combination and changes in key biomarkers and quality of life in this patient population.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older, be a man or a woman past menopause, and sign a consent form. Women taking medicine to stop their ovaries from working may also qualify.
- Have HR-positive, HER2-negative breast cancer, meaning it responds to hormones and does not have high levels of HER2 protein.
- Have a PIK3CA or AKT1 gene change, or loss of PTEN, confirmed by an FDA-approved test.
- Have cancer that has spread or cannot be cured with treatment in the breast area, and has worsened after hormone therapy and a CDK 4/6 inhibitor, a drug that blocks cancer growth.
- Have cancer that can be measured on scans. People with cancer only in the bones that cannot be measured may join the safety groups only.
- Be fully active or able to do light work. Have a body mass index (BMI), a weight-to-height measure, of at least 20.
- Have fasting blood sugar of 140 mg/dL or less. A1c, a measure of average blood sugar, must be 6.4% or less for alpelisib or below 8% for capivasertib.
- Have blood counts and organ function that meet study limits, be able to take pills, and fast for over 8 hours before certain visits. Have had no more than one chemotherapy treatment for cancer that has spread.
Who can't join
- Have inflammatory breast cancer, cancer that started in the brain, active cancer spread to the brain, or active or unstable nervous system problems.
- Have an allergy to any study drug or its ingredients, or cancer that worsened while taking fulvestrant alone.
- Have type 1 diabetes, uncontrolled type 2 diabetes, or have used insulin in the past 4 weeks.
- Have had major surgery within 30 days or minor surgery within 14 days before treatment, or have not recovered enough from surgery or earlier cancer treatment. Some recent radiation treatments also rule out joining.
- Have moderate or severe liver disease, uncontrolled HIV, ongoing lung inflammation or scarring, or digestive problems that could affect how the body absorbs the drugs.
- Have another cancer now or within the past 2 years, except certain treated skin or cervical cancers.
- Take certain medicines that cannot be stopped at least 7 days before treatment, including some drugs that affect drug breakdown and diabetes drugs such as glipizide or glyburide.
- Have had sudden swelling of the pancreas within the past year or long-term pancreas swelling. Unhealed bone death in the jaw also rules out alpelisib treatment.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion: 1. Patient is an adult male or postmenopausal female ≥18 years old at the time of informed consent(s) and has signed informed consent(s) before any trial related activities and according to local guidelines. 2. Patient with histologically and/or cytologically confirmed diagnosis of HR+, HER2- breast cancer, as determined by the local laboratory. 3. Patient has identified PI3K pathway alteration, defined as a PIK3CA mutation or PTEN loss or an AKT1 mutation using a Food and Drug Administration (FDA)-approved test, as determined either during Screening or was previously determined to have the alteration as evidenced by written documentation. 4. Patient has locally advanced (not amenable to curative therapy or metastatic) breast cancer meeting any of the following categories: * Relapsed disease, not amenable to curative therapy, with documented evidence of progressive disease (PD) following receipt of both (neo) adjuvant endocrine therapy and a CDK 4/6 inhibitor therapy (either alone or in combination with endocrine therapy) in the early stage or metastatic setting. * Newly diagnosed advanced breast cancer, with relapsed disease (i.e., documented evidence of PD) while receiving or after endocrine therapy plus a CDK 4/6 inhibitor. 5. Patient has measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. For bone lesions, lytic bone lesions or mixed lytic-blastic lesions, with identifiable soft tissue components, that can be evaluated by cross-sectional imaging techniques such as computed tomography (CT) or magnetic resonance imaging (MRI) can be considered as measurable lesions if the soft tissue component meets the definition of measurability per RECIST 1.1. Blastic bone lesions are non-measurable. For bone metastases only (without measurable lesions), patients may be accrued to the safety Cohorts only. 6. Patient has an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) ≤1 7. Patient has a Screening fasting plasma glucose (FPG) level ≤140 mg/dL (7.7 mmol/L) and an HbA1c ≤6.4% (47 mmol/mol) for those taking alpelisib, or an HbA1c \<8% (64 mmol/mol) for those taking capivasertib. 8. Patient has a body mass index (BMI) ≥ 20 kg/m2. 9. Patient is male or postmenopausal female. Postmenopausal is defined as any of the following: * ≥45 years of age and has not had menses for \>2 years. * Amenorrheic for \>2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation. * Post hysterectomy with oophorectomy. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. In case of oophorectomy alone, hormone level assessment (follicle-stimulating hormone, estradiol) will be done locally at Screening to confirm postmenopausal status. Patients who are on ovarian function suppression also qualify. 10. Patient is allowed prior fulvestrant treatment, provided they remain eligible for fulvestrant treatment. Patients whose disease progressed while receiving fulvestrant monotherapy are not allowed. 11. Patient is allowed prior mTOR or PI3K inhibitor treatment for patients otherwise eligible for capivasertib treatment. Likewise, patient is allowed prior mTOR or AKT treatment if they are otherwise eligible for alpelisib treatment. 12. Patient is allowed up to one (1) prior chemotherapy for their metastatic disease. 13. Patient agrees to, and is willing and able to arrive at the hospital/clinic in a fasted state (\>8 hours) on designated fasting days. 14. Patient has adequate bone marrow and organ function as defined by the following laboratory values: * Platelet count ≥140×109/L * In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×the upper limit of normal (ULN). If the patient has liver metastases, ALT and AST ≤5×ULN. * Total bilirubin ≤1.5×ULN except for patient with Gilbert's syndrome who may only be included if the total bilirubin is ≤3.0×ULN or direct bilirubin ≤1.5×ULN. * Fasting serum amylase ≤2×ULN. * Fasting serum lipase ≤1.5×ULN. * Hemoglobin ≥ 9 g/dL. * Absolute neutrophil count (ANC) ≥1500/mL. * Creatinine clearance ≥ 50 mL/min using either the Cockcroft-Gault equation or the CKD-EPI formula for calculation of eGFR, or has chronic kidney disease (CKD) grade ≤1 as evidenced by a treating nephrologist. Alternatively, a 24-hour urine test can be performed to confirm renal sufficiency. * Albumin ≥ 3.5 gm/dL. 15. Patient is able to take oral medications. Exclusion: 1. Patient has inflammatory breast cancer at screening. 2. Patient has known primary brain malignancy, active brain metastasis or active central nervous system pathology or is considered by the Investigator to be neurologically unstable. Furthermore, patients must not have received corticosteroids within 4 weeks of study entry and must have unchanged brain CT or MRI findings for at least two months prior to screening. 3. Patient has a known hypersensitivity to evexomostat, fulvestrant, alpelisib, or capivasertib, or to any of their excipients. 4. Patient has an established diagnosis of type 1 diabetes mellitus or uncontrolled (based on fasting plasma glucose \[FPG\] \>140mg/dL or HbA1c ≥6.5% for patients assigned alpelisib) or HbA1c for patients assigned to capivasertib, type 2 diabetes or has taken insulin in the 4 weeks prior to C1D1. 5. Patient has had major surgery within 30 days or minor surgery within 14 days prior to the first study drug dose, or has not recovered from major side effects from prior surgery. 6. Patient has ongoing toxicities related to prior anti-cancer therapies that have not resolved to Grade 0 for bone marrow toxicities or ≤Grade 1 for other toxicities, per National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v.5.0), with the exception of alopecia. 7. Patient has a Child Pugh score of B or C. 8. Patient has uncontrolled human immunodeficiency virus (HIV) infection. 9. Patient has received radio therapy ≤4 weeks or limited field radiation for palliation ≤2 weeks prior to enrollment, and who has not recovered to ≤Grade 1 from related side effects of such therapy (with the exception of alopecia) and/or from whom ≥25 percentage of bone marrow was irradiated. 10. Patient has a concurrent malignancy other than breast cancer or had a malignancy other than breast cancer within 2 years of enrollment, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer. 11. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the drug alpelisib or capivasertib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, gastric bypass or small bowel resection) based on Investigator discretion. 12. Patient has currently documented or unresolved pneumonitis/interstitial lung disease (the chest computed tomography \[CT\] scan performed before start of study treatment for the purpose of tumor assessment should be reviewed to confirm that there are no relevant pulmonary complications present). 13. Patient is currently receiving any of the following medications and cannot be discontinued at least 7 days prior to the start of the treatment: * Strong cytochrome P450 3A4 (CYP3A4) inducers * Inhibitors of breast cancer resistance protein (BCRP) * Sulfonylurea-based anti-diabetic drugs (e.g., glipizide, glyburide, etc.) 14. Patient has a history of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis. 15. Patient has unresolved osteonecrosis of the jaw (unless they are being considered for treated with capivasertib - i.e., this exclusion is only for patients being considered for alpelisib). 16. Patient has a history of severe cutaneous reaction, such as Stevens-Johnson Syndrome (SJS), erythema multiforme (EM), toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS). 17. Patient is currently receiving or has received systemic corticosteroids ≤2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment. Note: The following uses of corticosteroids are permitted: single doses (PO or IV), topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular). 18. Patient is nursing (lactating) or pregnant confirmed by a positive serum (hCG) test prior to initiating study treatment. 19. Patient participated in a prior investigational study within 21 days prior to the start of study treatment or within 5 half-lives of the investigational product, whichever is longer. 20. Patient has any other concurrent, severe and/or uncontrolled medical condition that would, in the Investigator's judgement, contra-indicate patient participation in the clinical study (e.g., chronic active hepatitis, severe hepatic impairment, recent cardiac events, uncontrolled heart disease) 21. Patient is not able to understand nor to comply with study instructions and requirements, including fasting requirements.
Study sites (10)
CA
- Loma Linda University Cancer Center · Loma Linda, CA 92354Lorena Garcia, CRC · Study contact · (909) 651-5612 · Lcgarcia@llu.eduGayathri Nagaraj, MD · Principal investigatorMore trials in Loma Linda
- Hoag Memorial Hospital Presbyterian · Newport, CA 92663Patrice Jones · Study contact · 949-764-5501 · patrice.jones@hoag.orgChaitali Nangia, MD · Principal investigatorMore trials in Newport
- SHARP Healthcare · San Diego, CA 92123Kristen Rice, MD · Principal investigatorMore trials in San Diego
FL
- Miami Cancer Institute at Baptist Health · Miami, FL 33176Xiaoou Pan · Study contact · xiaoou.pan@baptisthealth.netReshma Mahtani, DO · Principal investigatorMore trials in Miami
IL
- Hope and Healing Cancer Services · Hinsdale, IL 60521Srilata Gundala, MD · Principal investigatorMore trials in Hinsdale
MI
- Trinity Health · Ypsilanti, MI 48197Tareq Al Baghdadi, MD · Principal investigatorMore trials in Ypsilanti
OH
- Cleveland Clinic · Cleveland, OH 44195Azka Ali, MD · Principal investigatorMore trials in Cleveland
PA
- Penn State Milton S Hershey Medical Center · Hershey, PA 17033 · Study contact · 717-531-5471 · PSCI-CTO@pennstatehealth.psu.eduMonali Vasekar, MD · Principal investigatorMore trials in Hershey
TN
- Vanderbilt University Medical Center · Nashville, TN 37232The Vanderbilt-Ingram Cancer Center Patient Contact Line · Study contact · 1-800-811-8480 · cip@vumc.orgBrent Rexer, MD · Principal investigatorMore trials in Nashville
TX
- Doctors Hospital of Laredo · Laredo, TX 78045Alex Guerrero · Study contact · 956 693 1301 · alejandro.guerrero@uhsinc.comEduardo Miranda, MD · Principal investigatorMore trials in Laredo