FT836 for Advanced Solid Tumors

This trial explores a new treatment called FT836 for individuals with advanced solid tumors. Researchers aim to assess the safety and tolerability of FT836 when administered alone or with other cancer drugs such as paclitaxel, trastuzumab, or cetuximab. The trial seeks participants whose cancer has recurred or worsened after at least one other treatment and who have adequate organ function. Participants will be grouped to receive different combinations of these treatments to determine the best dose for future studies. As a Phase 1 trial, this research focuses on understanding how FT836 works in people, offering participants the opportunity to be among the first to receive this new treatment.

The trial requires that you have not received any biological therapy, chemotherapy, investigational therapy, or radiation therapy within 2 weeks or five half-lives before starting the study. This means you may need to stop certain medications before joining the trial.

Research has shown that FT836 has been effective against various solid tumors in lab studies, suggesting it might help treat advanced cancers. The main goal of the current research is to determine the safety and tolerability of FT836 in humans.

As one of the first studies of FT836 in humans, there is limited information about its side effects and overall safety, which researchers are closely monitoring.

The safety of FT836 combined with paclitaxel, a chemotherapy drug, is also under study. Paclitaxel is known to cause side effects like hair loss and fatigue, so researchers are examining how these might change with FT836.

For the combination of FT836 and cetuximab, previous studies have shown that cetuximab, used for certain cancers, can cause skin rash and low magnesium levels. The current study aims to see if these effects differ when used with FT836.

In the paclitaxel-cetuximab-FT836 combination, researchers are investigating how these drugs work together and whether the side effects are more or less severe.

For the FT836-trastuzumab combination, past research with trastuzumab, a breast cancer drug, has shown heart-related side effects. The study is checking if these occur when combined with FT836.

Finally, the paclitaxel-trastuzumab-FT836 combination is being studied to assess its effects on patients. Since both paclitaxel and trastuzumab have known side effects, this study is important to evaluate their safety with FT836.

Researchers are excited about FT836 for advanced solid tumors because it offers a novel approach compared to traditional treatments like chemotherapy and targeted therapies. Unlike standard options, which often focus on inhibiting tumor growth or targeting specific cancer cell markers, FT836 may work through a unique mechanism of action that hasn't been widely explored yet. Additionally, FT836 is being tested both as a standalone treatment and in combination with other known drugs such as Paclitaxel, Cetuximab, and Trastuzumab, potentially enhancing their effectiveness. This versatility and the innovative mechanism could lead to more effective treatment regimens, offering new hope for patients with advanced solid tumors.

Research has shown that FT836, which participants in this trial may receive, is effective against various solid tumors. Early studies suggest it works well without additional chemotherapy, as tested in Regimen A of this trial. In Regimen B, FT836 combines with the drug paclitaxel, and this combination has demonstrated lasting effects in fighting tumors. Regimen C explores combining FT836 with cetuximab, which may enhance its effectiveness against certain cancer cells. Additionally, Regimen E investigates using FT836 with trastuzumab, potentially improving its ability to fight tumors, especially in cancers that respond to trastuzumab. These findings suggest that FT836 could be promising for treating advanced solid tumors.²⁴⁶⁷⁸