SX-682 + Docetaxel for Head and Neck Cancers and Prostate Cancer

This trial tests a new drug, SX-682, combined with the existing chemotherapy drug, docetaxel, to treat head and neck cancers or prostate cancer that have spread or returned after treatment. The researchers aim to find better treatment options for these challenging cancers. Participants will take SX-682 as a tablet at home and receive docetaxel through an IV at the clinic. This trial may suit those who have experienced these cancers before and faced recurrence or spread despite previous treatments. As a Phase 1, Phase 2 trial, the research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

The trial requires that you stop taking any medications that are moderate or strong inducers or inhibitors of a specific liver enzyme (CYP3A4) at least 2 weeks before starting the study treatment. If you are taking medications for urinary symptoms like finasteride or dutasteride, you must stop them 1 week before starting the trial. If you are on hormonal therapies for salivary gland cancer, you may continue them during the trial.

A previous study found that docetaxel, a drug already approved for cancer treatment, works well for squamous cell cancer of the head and neck. This indicates it is generally safe and well-tolerated. Research shows that SX-682, when combined with other treatments, can enhance the body's immune response against tumors. Ongoing research on SX-682 suggests it might help treat cancer by inhibiting certain cells that promote tumor growth.

Unlike the standard treatments for head and neck cancers and prostate cancer, which often involve chemotherapy, radiation, or surgery, SX-682 offers a novel mechanism of action by targeting the tumor microenvironment. Researchers are excited about SX-682 because it inhibits the CXCR1/2 chemokine receptors, potentially reducing tumor growth and metastasis in a different way than traditional therapies. This innovative approach, when combined with the chemotherapy drug Docetaxel, could enhance treatment effectiveness and provide new hope for patients who haven't responded well to existing options.

In this trial, participants will receive a combination of SX-682 and Docetaxel. Previous studies have shown that SX-682 holds promise for treating head and neck cancers as well as prostate cancer. Research on mice with head and neck cancer found that combining SX-682 with Docetaxel produced strong anti-cancer effects. SX-682 blocks certain signals that cancer cells use to grow and spread, enhancing the immune system's ability to fight the tumor. Docetaxel is already known to significantly reduce deaths related to prostate cancer. Together, these drugs aim to enhance the body's ability to attack cancer cells more effectively.¹²³⁵⁶