TBio-4101 + Pembrolizumab for Advanced Solid Cancers

(STARLING Trial)

This trial tests a new treatment approach for various advanced solid cancers, using a combination of TBio-4101, a personalized immune cell therapy, and pembrolizumab, a cancer-fighting drug. Researchers aim to determine the effectiveness of this combination for cancers such as colorectal, lung, breast, and melanoma that have not responded to standard treatments. The trial includes different groups for each cancer type, allowing researchers to study the response of each group to the treatment. Individuals who have tried other cancer treatments without success and have specific types of cancer may be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative therapy.

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on chronic anti-coagulant therapy, it must be discontinued or temporarily changed. Also, if you are on chronic systemic steroid therapy or any other form of immunosuppressive treatment, you may not be eligible to participate.

Research shows that pembrolizumab, a drug used in this trial, has already received approval for treating several types of cancer, such as head and neck cancer and non-small cell lung cancer. This indicates it is generally well-tolerated when used alone. However, side effects like fatigue, nausea, and skin rash can occur.

For TBio-4101, limited information exists because it remains in early testing. This phase primarily assesses safety, aiming to identify any common or serious side effects. Although the full safety profile is not yet known, this treatment employs special immune cells called tumor-infiltrating lymphocytes (TILs) to attack cancer. This promising therapy requires careful monitoring for side effects.

Researchers are excited about TBio-4101 combined with Pembrolizumab because it offers a new approach in targeting advanced solid cancers. Unlike traditional therapies that might focus solely on disrupting cancer cell growth, TBio-4101 is designed to enhance the body's immune response specifically against tumor cells. Pembrolizumab, a known PD-1 inhibitor, works by freeing up the immune system to attack cancer more effectively, and when paired with TBio-4101, it could potentially amplify this immune response. This dual-action strategy aims to tackle cancers that have resisted standard treatments like chemotherapy or other PD-1 inhibitors, providing hope for better outcomes in challenging cases such as non-small cell lung cancer, colorectal carcinoma, and breast cancer, among others.

In this trial, participants will receive a combination of pembrolizumab and TBio-4101 to treat various advanced solid cancers. Previous studies have shown that pembrolizumab effectively treats several types of solid tumors, such as head and neck cancer and non-small cell lung cancer, by enhancing the immune system's ability to fight cancer cells. Research indicates that therapies like TBio-4101, which use the patient's own immune cells, can also boost the immune system's capacity to target and destroy cancer cells. Early findings suggest that combining pembrolizumab with TBio-4101 could enhance effectiveness against solid cancers. Although detailed human data on TBio-4101 remains limited, its mechanism appears promising for treating difficult cancers.¹²⁵⁶⁷