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!

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.

Who Can Join?
Amelia-1 Enrollment Criteria
Patients that meet the following basic criteria may be eligible to join the study:
- HR+ (estrogen or progesterone), Her2-, metastatic breast cancer
- PI3K pathway alteration: PIK3CA or AKT1 gene mutation, PTEN loss
- 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 Breast Cancer Clinical Trial 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
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
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
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
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
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
You've got questions? We've got answers.
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 >>