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The Amelia-1 Clinical Trial is enrolling now for breast cancer survivors with a PI3K pathway alteration. 


The Amelia-1 clinical trial is testing a new, experimental cancer treatment called Evexomostat to see if it improves clinical outcomes (better safety and efficacy)

when combined with either Piqray® or Truqap® and Faslodex®.

Hope is on the way!

Breast Cancer, Glucose and Insulin

Breast Cancer, Glucose

and Clinical Outcomes

Breast Cancer Clinical Study Patient

Evexomostat May Improve Insulin Sensitivity to Improve Your Treatment


The Amelia-1 clinical trial is testing whether adding evexomostat (SDX-7320) to either Truqap or Piqray plus Faslodex will help reduce the side effects of Truqap or Piqray and control your cancer longer.

●      Blood sugar spikes are a potentially serious side effect when taking drugs from the PI3K/AKT drug class, including Truqap and Piqray.

●      High fasting insulin, either caused by high blood glucose (sugar) or due to insulin resistance, can lead to disease recurrence and more aggressive disease.

●      Evexomostat is an experimental drug being developed for breast cancer patients like you that have an alteration in the PI3K/Akt pathway. Controlling high glucose could help improve clinical outcomes. 


Clinical Rationale for the Amelia-1 Trial

✔    In a Phase 1 clinical trial in late-stage cancer patients, evexomostat significantly improved insulin sensitivity in patients with insulin resistance.

✔    The mechanism of action of evexomostat (MetAP2 inhibition) has been clinically shown to help improve patients’ insulin sensitivity and also provide anti-tumor activity.

✔    In animal models of breast cancer with the PIK3CA gene mutation, evexomostat combined with either Truqap or Piqray worked synergistically to shrink tumors.

✔    In normal, healthy animals, evexomostat significantly lowered the glucose spikes caused by either Truqap or Piqray.


**All clinical trials come with risks. Have your oncologist explain the risks to you before considering joining the Amelia-1 Trial.

Clinical Study Breast Cancer Patient
Cloud 2
Amelia 1 Clinical Study Logo
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Who Can Join?

Clinical Study Eligibility Graphic
Clinical Study Eligibility Graphic

Amelia-1 Enrollment Criteria


Patients that meet the following basic criteria may be eligible to join the study:


  1. HR+ (estrogen or progesterone), Her2-, metastatic breast cancer
  2. PI3K pathway alteration: PIK3CA or AKT1 gene mutation, PTEN loss
  3. Previously treated with a CDK 4/6 inhibitor (e.g., Kisqali® or  Ibrance®) in 1st line setting

   4.  About to start 2nd line treatment for metastatic disease

⮚ Certain patients may be at increased risk for hyperglycemia (insulin resistant, high BMI).

⮚ There are other, more technical criteria that your health care provider or treating oncologist will review to be sure you qualify for the clinical study.

If you meet these basic criteria, you might benefit from this clinical study.

The Amelia-1 breast cancer clinical trial will enroll about 25-30 patients for each group initially to test the safety and efficacy for each of the three-drug combinations

(Evexomostat, Faslodex plus either Truqap or Piqray).

Additional patients may be added later.

Amelia 1 Clinical Trial Clouds

Amelia-1 Breast Cancer Clinical Trial Locations

Breast Cancer Clinical Trial Site Locations

To enroll, please have your oncologists contact one of our open
trial locations.

Note - additional study sites will be added as they complete qualification.

Hope and Healing Cancer Services
**Open for Recruitment

950 N. York Road, Suite 201A,

Hinsdale, IL, 60621

Contact: Praneetha Achanta pachanta@hopenheal.care

O: 630 560-0121 x106

F: 630-556-8014

Principal Investigator: Srilata Gundala, MD



Hoag Memorial Hospital Presbyterian

**Open to Recruitment

One Hoag Drive

Newport Beach, CA 92663

Contact: Jericho Rabago, BSN, RN

(949) 764-6796

jericho.rabago@hoag.org

Principal Investigator: Dr. Chaitali Nangia

Miami Cancer Institute, Baptist Hospital

**Open to Recruitment

8900 North Kendall Drive

Miami, FL 33176

Contact: Elaine Hernandez, Clinical Research Coordinator

ElaineHer@baptisthealth.net

Principal Investigator: Dr. Reshma L. Mahtani

Baptist Health Wellness and Medical Complex

**Open to Recruitment

1228 S Pine Island Rd.

Plantation, FL 33324

Contact: Krystal Fernandez , Clinical Research Coordinator

O:954-837-1490 ext.71566 krystalfernandez@baptisthealth.net

Principal Investigator: Dr. Reshma L. Mahtani

Vanderbilt University Medical Center

**Open to Recruitment

2220 Pierce Ave.

777 Preston Research Building

Nashville, TN 37232

(800) 811-8484

cip@vumc.org

Principal Investigator: Dr. Brent Rexer


Loma Linda University Cancer Center

**Open for Recruitment

11234 Anderson St.

Loma Linda, CA 92354

Contact: Lorena Garcia, CRC

(909) 651-5612

Lcgarcia@llu.edu

Principal Investigator: Gayathri Nagaraj, MD

University of Maryland School of Medicine

**Open to Recruitment

Marlene and Stewart Greenebaum Comprehensive Cancer Center

22 South Greene Street

Baltimore, MD

Contact: Nichole June-Williams

NJUNEWILLIAMS@umm.edu

Phone:410-328-7394

Principal Investigator: Katherine H.R. Tkaczuk, M.D.

Sharp Memorial Hospital
**Open for Recruitment

3075 Health Center Dr.

San Diego CA 92123

Principal Investigator: Kristen Rice, MD

Contact: Danica Griffin

Clinical Trial Cloud Graphic

You've got questions? We've got answers.

  • What Are the Risks of Taking Evexomostat?

    This is the first clinical study testing the combination of evexomostat, Truqap/Piqray and Faslodex together, so there could be unforeseen drug interactions or negative side effects.

    Evexomostat caused serious thrombocytopenia (low platelet count) in some patients in the Phase 1 safety study. While the issue resolved by itself, it can pose risks to patients with low platelets. Other risks as noted in the Phase 1 study include fatigue, diarrhea, constipation, nausea, brittle hair and nails. 

    The Patient Consent Form has more details on the risks associated with joining the study. Ask your oncologist about the potential risks before deciding to start the study.

  • Why Is Insulin a Bad Actor in Cancer?

    You probably already know that some of the cancer treatments you’ve received cause problems with weight gain, rising HbA1c, cholesterol/lipids, and your overall metabolic health. 

    What’s worse is that these metabolic complications - increased insulin in particular - may interfere with the effectiveness of your cancer treatment.


    Diet and exercise help lower insulin, but dieting can be a challenge while undergoing cancer treatment.


    We might have a solution… Evexomostat is the first experimental anti-cancer therapeutic being developed specifically for cancer patients with insulin resistance and other metabolic complications (either naturally occurring or caused by your treatment). It may also help improve the activity of your treatment and keep your cancer in check for longer. 


    View our paper on the relationship between breast cancer and insulin here >>

  • Amelia-1 Trial Information: Am I Eligible to Join?

    Patients that meet the following basic criteria may be a good candidate to join the study:

    ⮚ HR+ (either estrogen and/or progesterone), Her2-, metastatic breast cancer

    ⮚ Alteraion in the PI3K pathway, defined as a PIK3CA or AKT1 gene mutation or PTEN loss

    ⮚ about to start 2nd line treatment (previously treated with a CDK 4/6 inhibitor such as Ibrance® in the 1st line setting)

    ⮚ You have a fasting glucose level below 140 mg/dL PLUS you have either;

       o HbA1c below 6.4 inclusive OR

       o you are insulin resistant ( HOMA-IR score ≥1.8). This score is easy to get – it's calculated using fasting insulin and fasting glucose – your treating physician can order the test. 

  • I Meet the Basic Criteria, So How Do I Join?

    Your primary care physician or oncologist can refer you to one of the clinical trial sites, or you can reach out directly to the study coordinator or Investigator listed on this site.

    Here’s language you can cut/paste into an email to your physician:

    Dear Dr. [    ],

    I recently learned about a clinical study that I think I’d be a good fit for [https://amelia-1.com/]. If you agree, can you please make the referral to one of the study Investigators or coordinators?


  • What Are the Main Goals of This Study?

    The Amelia 1 Study hopes to show two things: 

    1. That evexomostat can help control treatment-induced blood sugar (glucose) spike and the high insulin stemming from high glucose, and

    2. That evexomostat can enhance the activity of Truqap/Piqray and Faslodex (better response rates, longer time before progression). 


    There are other, more technical objectives of the study, but these are the primary objectives.

  • Why is Controlling Blood Sugar So Important?

    High blood sugar is a bad actor - especially if you have cancer:

    • Cancer loves sugar!  Cancer cells grow faster and reproduce more frequently than other cells, and that takes a lot of energy. Sugar is a primary source of energy for cancer cells.
    • High blood sugar triggers an increase in your insulin (a protein made in your pancreas that moves sugar from your blood into your cells). BUT, insulin is also a growth hormone – not the kind of thing you want around if you have cancer!
    • Studies have reported that lowering glucose and insulin helps with staying on Piqray treatment longer, and could possibly extend survival.
    • Persistently high blood sugar would likely mean you’ll have to see an endocrinologist, take more medications, and possibly disrupt your cancer treatment while you get your blood sugar under control.
    • Evexomostat is being tested to see if it can help control blood sugar levels while improving the efficacy of Truqap/Piqray and Faslodex - a win-win.
  • Who can join the Amelia 1 Study?

    1. Patients that have metastatic breast cancer with an alteration in the PI3K pathway, including a PIK3CA or AKT1 gene mutation or PTEN loss

    2. Have already been treated with a CDK 4/6 inhibitor (palbociclib, ribociclib, etc.)

    3. Are post-menopausal

    4. Have a fasting plasma glucose <140 mg/dL AND HbA1c below 6.5.


  • What Is Expected of Me, If I Join the Amelia-1 Study?

    Why join a clinical trial? You help get new treatments to other breast cancer patients and you get special attention!


    But first things first.  If you meet the basic criteria, and you and your oncologist think this study may be good for you, you will be given a Patient Consent Form that explains everything to you about the Study and what’s expected of you. If you agree, you sign the form, and then you’ll be screened more thoroughly.


    To start, the study physician will verify you meet all the entry requirements. Assuming that goes to plan, you’ll be given a thorough physical exam along with a series of blood draws to establish a baseline, which will serve to help measure your progress on the study. Then you’ll return to the clinic according to schedule for treatments, follow-up visits, and (in the beginning) a few extra blood draws (added safety precautions).


    The Sponsor has agreed to reimburse transportation expenses and daycare (on site visit days) for mothers (all within reason).

  • How Do I Prepare for My Visits?

    You will need to come to clinical in a ‘fasted’ state, meaning you didn’t eat or drink anything (water is OK) for at least the past 8+ hours (morning appointments make this easy!). 


    Drinking only clear liquids (black coffee or tea with no milk/cream or sugar/sweetener) or water is fine, but NO juices or solid food of any kind until after your first blood draws – after that, it’s bon appetit!


    Fasting is critical to the study, as it’s how we measure if evexomostat is working.


    If your appointment is later in the day, you can come to clinic fasted, have your blood taken, then eat normally and return later for your treatment. 

  • How Often Will I Come to the Clinic?

    For the first couple of weeks, you’ll have to come in several times so the Investigator (oncologist running the study) can be sure you are tolerating the combination well, to check for any safety issues or signals (blood chemistries) and to ask you how you’re feeling. We realize it’s a bit of a burden, but it’s only for a few extra visits, and it’s really important to monitor you for safety. To help, we can cover your parking/transportation costs (within reason, and for sites that allow for reimbursement).

    After the initial several weeks, visits are once every 2 weeks for your evexomostat treatment (30 seconds to inject), to track your progress (take blood samples, ask you about your meds and how you feel) and to check on your overall health (once monthly questionaire).


    Faslodex is given at the same time as evexomostat (once every 2 weeks) for the first three doses, then once monthly. No special visits will be required for Faslodex.

    Both Truqap and Piqray are taken orally (by mouth) - Truqap with or without food twice daily or Piqray with food every day. You’ll start Truqap/Piqray two weeks after starting evexomostat and Faslodex.


  • How Long Will I Be on the Study?

    The Study lasts for 7 months, but you can remain on evexomostat as long as you are responding to treatment. The only requirement is that you come to the clinic fasted (no eating for at least 8 hours before arrival) once per month after the first 7 months so we can continue to monitor your progress.


  • What If I Want to Quit the Study?

    You can quit any time you want, for any reason, and it won’t impact your regular treatment. 


    However, if you do quit, you will no longer receive evexomostat. You should definitely talk with your doctor before making that important decision, though.


  • What If I'm Not Fasted When I Come to the Clinic?

    For us to know if evexomostat is helping control patients’ blood sugar levels, we need a ‘clean’ read on glucose.  Eating and/or drinking causes an immediate increase in blood sugar (as well as an increase in insulin levels) so if you eat before we check your blood sugar, we’ll get an artificially high reading and conclude it's not working for you.

     

    Patients who repeatedly come to clinic not fasted will be withdrawn from the study.


  • Will I get paid or compensated for joining the study?

    There is no compensation for joining the study aside from potential clinical benefit.


    However, if the site allows, the Sponsor may reimburse for transportation costs and reimburse for daycare costs (on site visit days only).


  • What If I Have More Questions?

    Your treating oncologist can inquire with the Investigators listed on this site, if either you or they have additional questions.


    The Patient Consent Form also provides greater detail on visits, risks and other matters.


  • Who Should I Contact About Joining the Amelia-1 Study?

    Depending on your location (see map ), you or your doctor can contact the Investigator or the study coordinator.


    Other sites may be opening, so keep checking back for updates.


VIDEO - Metabo-Oncology: The Critical Role Dysregulated Metabolic Hormones Play in Cancer Progression

Dr. Neil Iyengar, Memorial Sloan Kettering Cancer Center in New York City, explains the impacts of obesity/pre-diabetes on breast cancer progression and patient clinical outcomes in this video: Click to View the Video Here >>         

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