ReFocus Study

This ReFocus research study is a clinical trial for people whose cancer cannot be removed with surgery or has spread to distant parts of the body. The ReFocus clinical trial tests an investigational drug to learn if it can target and shrink tumors caused by FGFR2 gene alterations. The clinical trial has enrolled people with cancer around the world over the past 2 years.

Each person’s cancer has a unique pattern of biomarkers. Some biomarkers affect how certain cancer treatments work. This study is focused on cancers that have the FGFR2 gene alteration. Your doctor can request biomarker testing to determine if your cancer has FGFR2 alterations.

Who can join the ReFocus study? Do I qualify?

You may be able to join if you meet the following criteria*:

- You are an adult (18 years of age or older)
- You have a tumor with a documented FGFR2 alteration
- Your doctor can help you get tested to find out if your cancer has an FGFR2 alteration
- The cancer is unresectable, meaning it cannot be removed completely with surgery, or is metastatic, meaning the cancer cells have spread from the place where they first formed to another part of the body
- Cancers that may have an FGFR2 alteration include, but are not limited to, cholangiocarcinoma, breast, pancreatic, and gastric cancers

*Additional criteria may apply.

Patients should talk to their doctor about whether participating in a clinical trial may be right for them.

What will happen during the study?

Participation in the ReFocus study may last 3 months to 1 year or longer, depending on response to the study drug. If you qualify and decide to participate, you can expect the following stages of participation:

Consent

Review, ask questions, and sign the Informed Consent Form.

Screening

Participate in a study health assessment to confirm if you qualify for the study.

Study Drug

Receive 1 dose of RLY-4008 per day by mouth in 28-day cycles

Follow-up

Receive follow-up assessments every 12 weeks.

Participation in this clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.