Cancer Clinical Trial: Certain Solid Tumors including in Breast Cancer, Endometrial Cancer, and Colorectal Cancer

The ZINNIA study is evaluating an investigational drug called REC-7735 on its impact on safety for patients and preliminary effect against unresectable, locally advanced, or metastatic solid tumors with a PIK3CA H1047R mutation. This phase of the study will also look to determine the right dose amount. Questions the trial will aim to answer are:

• Is REC-7735 safe for patients with these certain solid tumors with a PIK3CA H1047R mutation (including breast cancer and endometrial cancer) and are there any side effects? 
• Will REC-7735 show any impact on tumor activity in these patients?
• What is the best dose(s) of REC-7735 that demonstrates some efficacy while managing any side effects?

Various factors about your health may exclude you. The study site physician will ultimately determine if you are eligible for the study but the following are some criteria specific to this study that would exclude you:

• If your disease has progressed while you have been treated with specific medicines called PI3Ka, AKT or mTOR inhibitors, you may not be able to take part in the study.
• If you have specific genetic changes known as “loss-of-function mutations in PTEN”, “PTEN loss”, or “activating mutations in AKT”, you may not be able to take part in the study.
• If you have cancer that has spread to the brain or spine and is causing symptoms, or if you have carcinomatous meningitis, you would not be able to take part in the study.
• If you have clinically significant UGT1A1 deficiency, including Gilbert’s syndrome, you would not be able to take part in the study.
• If you have had a major surgery within the 6 weeks leading up to the start of the study treatment, you would not be able to take part in the study.

Yes, some of your current cancer treatment may need to stop to take part in this study in order to understand what impact this investigational drug might have on your cancer. Please consult with the study site for more information.

In this trial, "open-label" means there is no placebo, and all study participants and doctors will know what you are taking. Every person who is eligible and enrolls in the study will receive the active investigational medication, REC-7735.

An investigational drug (also called an experimental treatment) is a substance that has not been approved by government regulatory agencies, such as the U.S. Food and Drug Administration (FDA), for use by the general public. Its safety and efficacy have not been established.

In many solid tumors, including in certain types of breast, colorectal, and endometrial cancers, a gene called PIK3CA develops a specific mutation known as H1047R. This mutation can act like a "broken switch" that is stuck in the on position, signaling cancer cells to grow, multiply, and survive even when they shouldn't. While there are existing medicines designed to block this switch, they often struggle to tell the difference between the "broken" mutation in the tumor and the "healthy" version of the protein that the rest of the body needs to manage blood sugar and metabolism. This can lead to side effects like high blood sugar (hyperglycemia).

REC-7735 is designed to be a highly selective inhibitor, specific for the H1047R mutation (also known as a “PI3Kα H1047R inhibitor”). It is designed to fit into the "broken" H1047R switch to inhibit it, lessen, or turn it off, while leaving the healthy version of the protein alone. We are studying REC-7735 to see how it works in patients, including whether it has an impact on their tumor growth and whether patients experience side effects. This will be the first time REC-7735 will have been administered to people.

REC-7735 is an oral medication taken twice a day by swallowing a tablet.

Participants who are eligible to join the study will visit the research site during the screening, treatment, safety follow-up, and disease progression follow-up (if applicable) periods.

Participation in the study will last up to approximately 2 years. At any time, once an enrolled participant's cancer gets worse or a participant experiences any severe side effects from treatment, they may be taken off study treatment.

If you are interested in enrolling in the trial, please contact your nearest study site or contact us to find a site nearest to you. You would then contact that site to discuss your options for participation.

This clinical trial is meant to study an investigational medication, meaning that neither the safety nor the effectiveness of the drug has been established. Taking part in this study may involve risks that are currently unknown. The known risks of taking part in this study will be explained to you during the informed consent process. If you are considering joining the trial, talk to your doctor about the clinical study. If you are interested in taking part, you will have the chance to ask questions and learn about these risks, so you can decide if the study is right for you. This would be the first time that the investigational drug will have been administered to people.

You do not need to pay to take part - there is no cost to participate in the ZINNIA study. If you are enrolled in the trial, you will be reimbursed for travel and other necessary expenses.

No health insurance is required to take part in the ZINNIA study.

If you take part in the ZINNIA study, you cannot join another study at the same time where you would receive an investigational drug. You may be able to take part in an observational study (a study where doctors track your health and symptoms over time without changing your treatment or introducing experimental treatments) that does not require you to take an investigational drug from that study.