Rezatapopt for Cancer

This trial explores how rezatapopt, a potential cancer therapy, affects certain other medicines in people with advanced solid tumors that have a specific change in the TP53 gene. The study aims to understand how rezatapopt interacts with drugs like metformin and rosuvastatin, commonly used to manage other conditions. This trial may suit individuals diagnosed with a TP53 Y220C mutation in their cancer who are not currently undergoing other cancer treatments. Participants will receive rezatapopt and undergo regular monitoring to assess how the treatment and other medications work together. 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 therapy.

The trial requires you to stop taking certain medications, including any systemic anticancer therapies, radiotherapy, and specific enzyme inhibitors or inducers, at least 14 days before starting the study drugs. Foods or drinks that affect certain enzymes, like grapefruit juice, should also be avoided.

Research has shown that rezatapopt is under investigation as a treatment for solid tumors with a specific TP53 gene alteration. In studies involving patients with this alteration, rezatapopt demonstrated promising results, benefiting 33% of all patients. It showed even better outcomes in certain cancers, such as ovarian cancer, where it helped 43% of patients.

Rezatapopt is unique because it targets cancer cells with a fresh approach, potentially offering a new option beyond traditional chemotherapy and immunotherapy. Unlike the standard treatments that often focus on attacking cancer cells directly or modulating the immune response, Rezatapopt may work by enhancing the sensitivity of cancer cells to metabolic stress. Researchers are excited about its potential to be taken orally, which could simplify treatment regimens and improve patient comfort compared to intravenous options. This novel mechanism and delivery method could open up new possibilities for treating cancer more effectively.

Research has shown that the drug rezatapopt, which participants in this trial will receive, may help treat solid tumors with a specific change in the TP53 gene, known as the Y220C mutation. Studies found that about one-third of patients with these tumors experienced tumor shrinkage. In patients with ovarian cancer and this mutation, the response was even better, with 43% experiencing tumor shrinkage, including at least one case where the tumor disappeared completely. For breast cancer patients, 18% saw their tumors shrink, while 60% of endometrial cancer patients experienced this benefit. These findings suggest that rezatapopt could be effective for several types of advanced cancers with this genetic change.¹²³⁵⁶