Sapanisertib for Bladder Cancer

This trial tests how well the drug sapanisertib can treat bladder cancer that has spread beyond its original site. Researchers aim to determine if sapanisertib can halt cancer cell growth by blocking certain essential enzymes. The trial targets individuals with bladder cancer that has specific DNA changes (TSC1 or TSC2 mutations) and who have not responded to at least one type of platinum-based chemotherapy. Those with metastatic bladder cancer and these DNA changes might qualify for this study. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

The trial does not specify if you need to stop taking your current medications, but you cannot take certain medications like strong inhibitors or inducers of specific enzymes (CYP3A4, CYP2C19, CYP2C9) and proton pump inhibitors. It's best to discuss your current medications with the study team.

Research has shown that sapanisertib is generally safe. In earlier studies, patients with various cancers, such as kidney and endometrial cancer, tolerated the treatment well. Some side effects occurred, but they were manageable.

Another study found that when combined with another drug, most participants managed the side effects without major issues.

Sapanisertib is unique because it targets the mTOR pathway, which is a key driver in the growth and survival of cancer cells, including those in bladder cancer. Most current treatments for bladder cancer, like chemotherapy and immunotherapy, do not specifically target this pathway. Researchers are excited about sapanisertib because its targeted approach could potentially overcome resistance to these existing therapies and offer a new option for patients who have limited response to standard treatments. Additionally, sapanisertib is administered orally, which could offer a more convenient treatment option compared to intravenous therapies.

Research has shown that sapanisertib, which participants in this trial will receive, might help treat bladder cancer in individuals with TSC1 and TSC2 mutations. Earlier studies found that sapanisertib blocks certain enzymes that aid cancer cell growth. In some bladder cancer patients, this treatment has shown promise in slowing tumor growth. It targets specific parts of the cancer cells, making it a focused treatment for those with the right genetic mutations. While more research is needed, these early results suggest potential benefits for patients with these specific cancer mutations.¹²³⁴⁶