Clinical research studies, or trials, help scientists and doctors evaluate the safety and effectiveness of new medical treatments. The study may take place at a hospital, clinic, university, or doctor’s office.

Boundless Bio, a biopharmaceutical company, is sponsoring the trial, which is being conducted by oncologists or cancer doctors at the clinical trial sites.

Investigational means that the therapy has not been approved for medical use and is currently being studied to understand its safety and effectiveness. Studies of investigational therapies may only be performed with the permission of, and under the oversight of, the regulatory authority of the country where the study is being conducted, such as the US Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in Europe.

As a part of this study, you will receive a commercially available anti-cancer therapy that targets EGFR if you have a cancer with EGFR amplification, or you will receive a commercially available anti-cancer therapy that targets FGFR if you have a cancer with FGFR amplification. Each of these cancer therapies will be given in combination with the investigational therapy, BBI-355.

While these anti-cancer therapies are commercially available (not BBI-355), neither have been approved to treat cancer with gene amplification.

EGFR stand for Epidermal Growth Factor Receptor and is a protein on cells that helps them grow, survive, and multiply.  Amplification of this gene can cause cancer to develop and spread.

FGFR stands for Fibroblast Growth Factor Receptor and is a protein on cells that helps them grow, survive, and multiply.  Amplification of this gene can cause cancer to develop and spread.

This type of information about your cancer is called genomic information.  In order to understand the genomic information about your cancer, a sample of your tumor, or sometimes a sample of your blood, will be tested for the presence of EGFR, FGFR and other genomic biomarkers.  This type of testing is called next-generation sequencing, or ‘NGS’ testing. Ask your oncologist about your next-generation sequencing (NGS) report.  NGS testing and the resulting NGS report may have been done by any of these, or other, testing companies - Foundation, Tempus, Guardant, or Caris, and will contain genomic information about your cancer, including whether you have EGFR or FGFR amplified cancer.

Typically, on the first or second page of the report you will see a list of genes in “Genomic Findings” or “Genomic Variants” or “Molecular Findings”.  On this list, you may see genes with “amplification” or “copy number gain”.  If your report includes EGFR, FGFR1, FGFR2, or FGFR3 genes with amplification or copy number gain, you may be eligible for the study. 

Click here to see where to look on your NGS report >>

The oncology care team at the clinical trial site will explain in detail to you what participation in the POTENTIATE study means for you.  Participation is completely voluntary, and you are permitted to change your mind about participation at any time.

 People choosing to participate will be asked to do the following:

• Attend visits and have assessments such as blood draws to find out if you qualify for the study.

• Take the investigational therapy in combination with another cancer therapy, as directed by the study doctor.

• Participate in follow up appointments including additional blood draws and tumor imaging (scans).

The length of time on study depends on how your body responds to the treatment.  You will always have the option to stop. 

You or your doctor can contact an Investigator or the study coordinator at any of the clinical trial sites.

 View the Site Map Here >>

Your primary care physician or oncologist may be able to refer you to one of the clinical trial sites. Travel support may be available to help you travel to one of the clinical trial sites.

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