XL092 + Immunotherapy for Cancer

(STELLAR-001 Trial)

This trial examines a new cancer treatment called XL092, both alone and in combination with other drugs, to assess its safety and effectiveness against advanced solid tumors. Researchers aim to determine if these treatments can slow or halt tumor growth. Suitable candidates have a type of cancer that cannot be surgically removed and have not responded to previous treatments. As a Phase 1 trial, this research seeks to understand how the treatment works in people, providing participants the opportunity to be among the first to receive it.

The trial requires that you stop taking certain medications before starting the study treatment. Specifically, you must not have taken any small molecule kinase inhibitors within 2 weeks, or anticancer antibodies, systemic chemotherapy, or hormonal anticancer therapy within 4 weeks before the first dose. Additionally, certain medications cannot be used during the trial.

Research has shown that XL092, the main treatment in this study, has a manageable safety profile based on previous studies. No unexpected side effects have been reported, indicating that side effects generally align with those anticipated from similar treatments. XL092 is a new oral drug targeting specific proteins involved in cancer growth.

Reports indicate that when combined with avelumab, another cancer treatment, some serious side effects have occurred. Avelumab can cause strong immune reactions in the body, potentially affecting any organ or tissue.

For the combination of XL092 and atezolizumab, studies are still ongoing. While specific safety results for this combination aren't detailed, atezolizumab itself is known to carry risks of serious immune reactions.

Researchers are excited about XL092 because it represents a new approach to cancer treatment. Unlike standard care options that often target cancer cells directly, XL092 is a small molecule inhibitor that works by blocking specific pathways that tumors use to grow and spread. This targeted mechanism of action has the potential to be more precise and may offer effectiveness with potentially fewer side effects. Additionally, when combined with immunotherapies like Avelumab and Atezolizumab, XL092 could enhance the immune system's ability to fight cancer, offering a promising new strategy in the fight against cancers such as renal cell carcinoma, breast cancer, prostate cancer, and colorectal cancer.

Research has shown that XL092, a new oral medication, targets key proteins that aid cancer growth and spread. In this trial, some participants will receive XL092 alone, which early studies have shown to stop tumor growth. Others will receive XL092 with atezolizumab, a drug that helps the immune system fight cancer and has initially improved outcomes for certain cancers. Atezolizumab is already approved for some cancers, adding confidence in its use. Additionally, some participants will receive XL092 with avelumab, another drug that boosts the immune system and has shown activity against tumors, especially in advanced breast cancer. These treatments aim to halt cancer cell growth and spread while strengthening the body’s natural defenses.⁵⁶⁷⁸⁹