AVA6103 for Cancer

(FOCUS-01 Trial)

This trial tests a new treatment called AVA6103 for individuals with certain types of advanced or spreading cancers that are FAP positive. The main goal is to determine a safe dose of AVA6103 and assess its impact on the cancer. Participants will receive the treatment intravenously, with varying dosage schedules, to evaluate its effectiveness and potential side effects. This trial suits individuals with advanced cervical, vulvar, small cell lung, gastric, or pancreatic cancers who have exhausted all standard treatment options or are ineligible for them. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

The trial requires that you stop taking certain medications, such as St John's Wort and drugs that strongly affect specific liver enzymes and proteins, at least 5 days before starting the trial. If you're on any of these medications, you'll need to discuss with the trial team about stopping them.

A previous study showed that AVA6103 targets cancer cells specifically by activating in the tumor environment, reducing the risk of harming healthy cells. Preclinical data, from tests conducted in labs or on animals before human trials, suggest that AVA6103 is generally well-tolerated and has limited effects on non-target areas.

This is a first-in-human Phase 1 trial, marking the first time AVA6103 is tested in people. The main goal is to determine its safety and find the best dose. As this is an early stage, information on human responses to the treatment is limited.

Researchers are excited about AVA6103 because it introduces a novel approach to cancer treatment, which could potentially differentiate it from current standard treatments like chemotherapy and targeted therapies. Unlike most treatments that target cancer cells directly, AVA6103 may work by engaging the immune system more effectively, potentially leading to better outcomes. Additionally, the treatment's unique mechanism of dose escalation in different intervals (every two weeks or every three weeks) allows for a tailored approach that could minimize side effects while maximizing the therapeutic effect. This innovative approach offers hope for patients who have not responded to existing treatments.

Studies have shown that AVA6103 targets cancer cells by delivering the drug exatecan directly to the needed area. This drug kills cancer cells and can also affect nearby cancer cells, a process known as the bystander effect. Research indicates that AVA6103 maintains a strong concentration of exatecan in the tumor for several days, which may help shrink the tumor effectively. Additional evidence shows that AVA6103 works better than exatecan alone, offering improved tumor growth control and longer-lasting effects even after stopping treatment. These findings suggest that AVA6103 could be very effective in treating certain cancers, especially those with a specific protein called FAP that AVA6103 targets. Participants in this trial will receive AVA6103 in different dosing schedules, including Phase 1a dose escalation every three weeks (Q3W) or every two weeks (Q2W), and Phase 1b dose expansion at the recommended phase 2 dose.²⁴⁵⁶⁷