Testing a new combination treatment for advanced cancers that haven't responded to standard therapy

Plain-English translation of NCT05733000 on ClinicalTrials.gov ↗ · Source last updated March 2023 · Translation generated July 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing a medication called (also known as CPI-613) combined with and either 5- or gemcitabine. These three drugs together are being tested to see if they can shrink or slow down several types of advanced cancers that have stopped responding to standard treatments. The study will enroll about 94 people and track how well this combination works and how safe it is.

When advanced cancers stop responding to standard treatments, patients need new options. This medication combination works on cancer cells in a different way than traditional therapies, offering hope for people whose cancers have become resistant to other drugs.

Do you qualify?

You likely qualify if…

you have been diagnosed with advanced colorectal, pancreatic, gastroesophageal, biliary, urothelial, ovarian, or lung cancer that has spread or no longer responds to standard treatments
your cancer is confirmed by a biopsy or tissue sample and cannot be cured by standard treatments or you cannot tolerate them
you have measurable disease that can be seen on scans taken within the last 6 weeks
you are at least 18 years old and in good enough health to receive cancer treatment (Eastern Cooperative Oncology Group performance status 0 or 1)
you have already tried all available targeted therapies and immunotherapies, such as checkpoint inhibitors
your blood work shows adequate kidney, liver, and bone marrow function within the last 2 weeks

You likely don't qualify if…

you have not exhausted other available targeted therapies or immunotherapies
your blood counts (white blood cells, red blood cells, or platelets) are too low
your kidney or liver function is too severely impaired
you have active bleeding or blood clotting problems that cannot be controlled
you have severely elevated liver enzymes or bilirubin levels

What participation looks like

You will receive the medication combination intravenously (through an IV) and take one of the medications by mouth. Throughout the study, you'll have regular visits for blood tests and imaging scans (CT or MRI) to see how your cancer is responding. The trial will track how long you survive, how long your cancer stays controlled, and what side effects you experience. Some participants may also have additional blood samples taken for research purposes to better understand how the medications work.

Testing a new combination treatment for advanced cancers that haven't responded to standard therapy

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)