Clinical Trial Q&A:
Information about Angiex trials
Angiex believes that “No one should die of cancer.”
We are committed to our mission of exploiting the advantageous biology of TM4SF1 to gain revolutionary power over cancer.
For those cancer patients considering participation in an Angiex clinical trial, here are some common questions and answers. If you have questions that are not addressed here, you can email us at trials@angiex.com.
Angiex currently is conducting the following clinical trials:
Program
Clinical Phase
Indications
ClinicalTrials.gov ID
AGX101
1
- All solid cancers
- Angiosarcoma
At what clinical stage is AGX101?
AGX101 is an experimental drug which is in a Phase 1 clinical trial. It has not been proven safe or effective, and much remains to be learned about its optimal methods of use and potential effects.
How do I inquire about enrolling in an AGX101 clinical trial?
To inquire about enrollment in a clinical trial, please get in touch with a recruiting contact at one of the study locations listed at ClinicalTrials.gov. Currently these are:
Site
Location
Investigator
Recruiting Contact
Phone
Sarah Cannon Research Center
Nashville, TN
Meredith Pelster, MD
Rebecca Beaman
NEXT Oncology
San Antonio, TX
Ismael Rodriguez-Rivera, MD
Amanda Betancourt
NEXT Oncology
Fairfax, VA
Alexander Spira, MD
Blake Patterson
University of Southern California
Los Angeles, CA
Diana Hanna, MD
Xiomara Menendex, RN
Sites expected to join the trial include sites in these locations: St Louis MO; Sarasota FL; and Houston TX.
Who is eligible to participate in an AGX101 clinical trial?
To be eligible to participate, you must:
- have unresectable, locally advanced, or metastatic solid tumors; and
- have experienced disease progression on, or declined to take, all approved therapies for your cancer.
Certain cancers are excluded from the trial at this stage – for example, patients with brain tumors or an unresected colon tumor. Patients must also have adequate organ function, for example platelet count > 80,000/μL, absolute neutrophil count (ANC) ≥ 1500/µL, and left ventricular ejection fraction (LVEF) ≥ 50%.
The recruiting contacts at study locations can provide further guidance on eligibility. Please note that a screening process is conducted at the study location to confirm eligibility.
Angiosarcoma is listed as an indication of special interest. What is special about angiosarcoma?
TM4SF1 is an endothelial cell biomarker which is highly upregulated in endothelial cells that have been activated for growth. Angiosarcoma cells are cancer cells of endothelial origin that are growing, and in resected angiosarcomas studied by Angiex, angiosarcoma cells highly express TM4SF1. As a result, it is reasonable to expect angiosarcoma cells to be sensitive to AGX101.
Angiosarcoma is a high unmet need cancer with few treatment options. Therefore, there is a significant potential for AGX101 to provide angiosarcoma patients with a clinical benefit.
What kind of adverse effects are expected from treatment with AGX101?
As our experience to date is based on data from a small number of patients, it is too early to generalize about adverse effects. As an experimental drug in Phase 1, much remains to be learned about potential effects of AGX101.
That said, expected effects of the drug may include symptoms of tumor lysis, such as nausea, fatigue, or muscle aches; and hemostatic or inflammatory responses to vascular injury, such as a drop in platelet count or a rise in C-reactive protein.
Patients on trial should report adverse effects to their treating physician.