9-ING-41 + Retifanlimab + Chemotherapy for Pancreatic Cancer

(RiLEY Trial)

This clinical trial tests a new combination of drugs for individuals with advanced pancreatic cancer. The goal is to determine if 9-ING-41 (an experimental treatment) and Retifanlimab (an immunotherapy drug), when combined with standard chemotherapy, are safe and effective. Participants should have pancreatic cancer that has not previously been treated with chemotherapy for advanced stages. The trial will begin with a few patients to ensure safety and may adjust doses based on results. 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 treatment combination.

The trial protocol does not specify whether you need to stop taking your current medications. However, you must not be receiving any other investigational medicinal product and should not have received systemic antibiotics within 7 days prior to the first dose of the study drug.

Research has shown that 9-ING-41, also known as elraglusib, has been tested for safety in other studies. Some patients experienced more side effects when combined with other cancer treatments, leading to an adjusted dose of 9.3 mg/kg twice a week.

Retifanlimab is an immune therapy that blocks PD-1, a protein that can prevent the immune system from attacking cancer cells. It has been used to treat certain skin and anal cancers. The side effects are typical for this kind of treatment, expected but manageable, and can vary among individuals.

Researchers are excited about 9-ING-41 combined with Retifanlimab for pancreatic cancer because it targets the disease in new ways that current treatments don't. While standard treatments like FOLFIRINOX rely on conventional chemotherapy, 9-ING-41 is a GSK-3β inhibitor, which may disrupt cancer cell survival pathways, making it harder for tumors to grow. Retifanlimab is an immune checkpoint inhibitor that helps the immune system better recognize and attack cancer cells. This combination offers a unique approach by potentially halting cancer growth and boosting the body's own defenses against the disease.

In this trial, participants will receive a combination of 9-ING-41, Retifanlimab, and chemotherapy. Research has shown that 9-ING-41, a drug targeting a protein linked to cancer growth, may help overcome resistance to standard chemotherapy in pancreatic cancer. Studies have found that this drug, when combined with Retifanlimab, could enhance the effectiveness of chemotherapy. Retifanlimab is known to assist the immune system in fighting cancer. Early findings suggest that using these treatments together might improve outcomes for pancreatic cancer patients. By attacking the cancer in several ways, this combination aims to be more effective than standard treatments alone.⁶⁷⁸⁹¹⁰