An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants with Advanced Solid Tumors

IDE397 is an investigational drug, which has not been approved by health authorities for the treatment of people with your medical condition. It is currently not “on the market” (available for you to receive a prescription for and/or to buy) in any country. In this study, different dose levels of IDE397 will be tested. About 40 patients are expected to participate at approximately 6-8 study centers within the US. At a minimum, 2 patients will be enrolled in each dose level. There will be about 10 dose levels tested (starting at 5 mg). Every time a dose level is found to be safe, a new dose level will be tested in a new group of patients until the most appropriate dose is determined. Patients in the lower dose level may receive IDE397 at the next dose level that is determined to be safe. The main goals of the study are to determine to what extent IDE397 is safe and tolerated, the highest dose of IDE397 that is safe, the effects, good and/or bad, IDE397 has on patients and on their disease, how quickly the study drugs are removed from patients’ bloodstream (this is called pharmacokinetics [PK]), and how the drug works in your body and on your cancer (this is called pharmacodynamics [PD] and biomarker collections).

Are you Eligible? (Inclusion Criteria)

• You are atleast 18 years of age or older
• You have a type of cancer that is considered a “solid tumor” (not a blood
• cancer) that is caused by an error in your tumor DNA associated with the gene,
• methylthioadenosine phosphorylase (MTAP).
• You must have loss of this MTAP gene to participate in the study.