The purpose of this study is to find the best amount and timing of indocyanine green to create enough difference in brightness between the tumor and normal tissue, and to check whether this glowing effect can help surgeons accurately identify the edges of tumors during surgery. The study will look at how well the fluorescence imaging, which is a technique that uses special cameras to see the glowing substance, matches with what is found when tissue is examined under a microscope after removal. Researchers will also count how many additional glowing areas are found and confirmed to be cancer, as well as cases where the glow incorrectly suggests cancer when there is none or misses cancer that is present.

During the study, patients who are already planned to have surgery to remove their cancer will receive an infusion of indocyanine green before or during their operation. Surgeons will use special cameras that can detect the fluorescence to look at the tumor area and the surrounding tissue. The removed tissue and any lymph nodes will be examined both with the fluorescence camera and later under a microscope to compare the results. The study will measure the brightness difference between tumor and normal tissue, check whether the edges of the removed tissue are free of cancer cells, and record any side effects that occur. The goal is to determine if this imaging method can help surgeons remove cancer more completely while preserving healthy tissue.

The medication being tested, fadraciclib, is taken by mouth in tablet form. It belongs to a group of drugs called CDK2/9 inhibitors, which work by blocking certain proteins that help cancer cells grow. The study aims to find the best dose of the medication and determine how well it works in treating these different types of cancer.

During the study, participants take the medication either once or twice daily in 28-day cycles. The treatment continues as long as it is helping and the side effects are manageable. Throughout the study, doctors monitor the participants’ health and how their cancer responds to the treatment. This includes regular check-ups and various medical tests to ensure safety and track the effectiveness of the medication.

The study is divided into two parts. In the first part, participants will receive DS-3939a to assess its safety and how well it is tolerated by the body. In the second part, the study will continue to evaluate safety and also measure the treatment’s effectiveness at a recommended dose. This will involve looking at how the cancer responds to the treatment, which is known as the objective response rate. Participants may have different types of advanced cancers, including those of the lung, breast, ovary, and pancreas, among others.

Throughout the study, participants will be closely monitored for any side effects or changes in their health. This includes regular check-ups, laboratory tests, and imaging studies to track the progress of the treatment. The study aims to gather important information that could lead to new treatment options for people with advanced solid tumors. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of DS-3939a.