There are many genes involved in the development of cancer. In some people, the affected genes involved in the cancer could be TSC1 or TSC2. These genes can be found in many types of solid tumors. Changes, called mutations, in these genes are believed to be associated with different types of cancer, including:

Aadi Bioscience is sponsoring a clinical trial called PRECISION 1 that is investigating whether an investigational medication called nab-sirolimus can affect patients with advanced or metastatic solid tumors.

In order to be eligible for the PRECISION 1 clinical trial, a patient must have a solid tumor with a mutation of the TSC1 or TSC2 gene.

The safety and efficacy of nab-sirolimus for this use have not been established.

Who Is Eligible for the Trial?

To be eligible for the PRECISION 1 trial, a patient must:

• Be at least 12 years old
• Have not used any other mTOR inhibitors (for example, everolimus or temsirolimus)
• Be able to perform normal daily activities
• Have a solid tumor with the TSC1 or TSC2 mutation that is metastatic or cannot be surgically removed
• Have received all other appropriate standard treatment options as determined by your doctor

To determine whether you have a TSC1 or TSC2 mutation, a doctor will take a biopsy of the tumor and have it analyzed using a technology called next generation sequencing (NGS).

What Happens During the Trial?

All participants in the PRECISION 1 trial will receive the study drug, nab-Sirolimus, on day 1 and day 8, and then take a week off. Then the 21-day cycle repeats: Once a week for 2 weeks followed by 1 week off. The drug is given by intravenous (IV) infusion, which takes about 30 minutes.

If you do not tolerate the drug well, your doctor may decide to try a lower dose. You will continue to receive the drug until your disease progresses, you experience unacceptable side effects, or you choose to stop participating.