Futibatinib + Paclitaxel + Ramucirumab for Stomach Cancer

This trial explores a new combination of three treatments—futibatinib (a potential new drug), paclitaxel, and ramucirumab—for certain types of stomach cancer that have spread or cannot be removed by surgery. The goal is to assess the safety of this combination and determine the optimal dose to inhibit cancer cell growth. Individuals with stomach or esophageal cancer that cannot be surgically removed and have not undergone more than one prior treatment may be suitable candidates for this study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot participate if you are receiving other investigational agents or anticancer therapies within 21 days before the trial starts.

Research has shown that futibatinib, paclitaxel, and ramucirumab each have safety data from previous studies. Futibatinib has generally been safe for people with advanced solid tumors, including stomach cancer, meaning most did not experience severe side effects beyond expected levels.

Paclitaxel and ramucirumab have been used together in people with advanced stomach cancer and are usually well-tolerated. Studies indicate that this combination can effectively treat cancer with predictable and manageable side effects.

Researchers are excited about the combination of futibatinib, paclitaxel, and ramucirumab for treating stomach cancer because it introduces a novel approach compared to current options. Futibatinib works by targeting FGFR (fibroblast growth factor receptor) pathways, which are not commonly addressed by standard treatments like chemotherapy and HER2 inhibitors. This unique mechanism might offer benefits for patients whose cancer doesn't respond well to traditional therapies. Additionally, combining futibatinib with paclitaxel and ramucirumab, which are already established in treating various cancers, may enhance overall effectiveness and provide a more comprehensive attack on the cancer cells.

Research has shown that combining paclitaxel and ramucirumab effectively treats advanced stomach cancer. One study found that this combination helps patients live longer compared to paclitaxel alone. Paclitaxel stops cancer cells from growing and dividing, while ramucirumab prevents the formation of new blood vessels that tumors need to grow. In this trial, participants will receive a combination treatment that includes futibatinib, which has demonstrated some ability to fight tumors in patients with stomach cancer. Futibatinib works by blocking enzymes that cancer cells need to grow, potentially stopping tumor growth. These findings suggest that this combination could be helpful for treating stomach cancer that is difficult to remove or has spread.¹²³⁴⁵