AMXI-5001 for Advanced Cancers

This trial tests a new treatment, AMXI-5001, for people with advanced cancers that haven't responded to other treatments. In the first part, researchers will determine the optimal dose. In the second part, they will assess its safety and effectiveness. This study seeks participants whose cancers have not improved with existing treatments and who are not currently undergoing any cancer treatment. As a Phase 1/Phase 2 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects and measuring its initial effectiveness.

The trial requires that you stop using strong inhibitors or inducers of CYP3A4 (a liver enzyme) within 7 days before starting the study and throughout the trial. This includes some antibiotics, antifungals, anticonvulsants, and grapefruit. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Research shows that AMXI-5001 is being tested for safety in people with advanced cancers. Treatments for these cancers can often cause severe side effects. The trial aims to determine the right dose of AMXI-5001 to minimize these effects.

AMXI-5001 is in the early testing stages, with researchers closely monitoring for any side effects. This phase is crucial to ensure the treatment's safety before larger studies.

AMXI-5001 is unique because it targets cancer cells differently than current treatments. While many existing therapies, like chemotherapy and radiation, work by attacking both healthy and cancerous cells, AMXI-5001 is designed to selectively target cancer cells, potentially reducing side effects. Researchers are excited about its novel mechanism of action, which involves a new active ingredient that may provide more effective results in treating advanced cancers. This targeted approach not only has the potential to improve outcomes but also to enhance the quality of life for patients by minimizing harm to healthy cells.

Research has shown that AMXI-5001 could effectively treat advanced cancers. In studies, AMXI-5001 killed cancer cells in 110 different types of human cancer, including challenging ones like ovarian, prostate, pancreatic, and breast cancer. The treatment attacks and breaks down cancer cells, hindering their survival and growth. Although more research is needed to confirm these benefits in people, early results are promising for those whose cancers have not responded to other treatments. In this trial, all participants will receive AMXI-5001.¹²³⁶⁷