BBI-940 + Fulvestrant for Breast Cancer

(KOMODO-1 Trial)

This trial tests a new treatment called BBI-940 for individuals with advanced breast cancer. Researchers are studying BBI-940 alone or with fulvestrant (a hormone therapy) to assess its safety and effectiveness. The trial seeks participants with specific types of breast cancer, such as estrogen receptor-positive or triple-negative with certain characteristics. Participants should have previously tried standard treatments but still require other options. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

The trial protocol mentions a 'washout period' (time without taking certain medications) for recent anticancer therapy, but it doesn't specify about other medications. It's best to discuss your current medications with the trial team to get specific guidance.

Previous studies have shown that Fulvestrant is a safe and well-tolerated treatment for advanced breast cancer that is hormone-receptor-positive and HER2-negative. Some patients experienced side effects like nausea and diarrhea, but serious side effects were uncommon.

BBI-940 remains in the early stages of testing, so complete safety information is not yet available. As this is the first human trial for BBI-940, the primary goal is to assess its safety. Early lab tests suggest it targets cancer cells effectively, but researchers are closely monitoring for any side effects in people.

Researchers are excited about BBI-940 because it offers a fresh approach to treating ER+/HER2- breast cancer, especially in cases without an ESR1 mutation, where the standard treatments usually involve hormone therapies like tamoxifen or aromatase inhibitors. BBI-940 works by targeting specific pathways that are not typically addressed by existing hormone therapies, potentially offering a new line of defense against cancer cells. Additionally, BBI-940 is taken orally, making it a more convenient option compared to some existing treatments that require intravenous administration. This novel mechanism and delivery method could mean fewer side effects and greater convenience for patients.

Research has shown that BBI-940 targets specific proteins called kinesins, which assist cancer cells in dividing and growing. This treatment aims to reduce cancer cell survival by eliminating extra DNA that often promotes cancer growth. Early studies have shown promising results, with BBI-940 reducing cancer cell numbers in breast cancer models. In this trial, some participants will receive BBI-940 combined with fulvestrant, which blocks estrogen—a hormone many breast cancers require for growth. This combination aims to enhance effectiveness by attacking the cancer in multiple ways. Other participants will receive BBI-940 alone, either in dose escalation or at the recommended dose for expansion, to further evaluate its effectiveness.¹²³⁵⁶