Adaptive Phase III Study of KESONOTIDE17, a New hGIIA-Vimentin Inhibitor, in Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating KESONOTIDE12, a new drug that inhibits the hGIIA-vimentin protein, in adults with advanced or metastatic solid tumors including prostate, breast, lung, ovarian, glioblastoma, pancreas, and skin cancers. This adaptive phase III trial aims primarily to assess the safety and tolerability of KESONOTIDE12 when given alone. The study also looks at how the drug moves through the body. The trial is open-label and multicenter, enrolling about 20-32 participants in phase I and around 80 in phase II. In phase I, participants receive escalating single doses of KESONOTIDE12 orally at 10mg, 30mg, 60mg, or 120mg to find the best dose with acceptable side effects. Phase II will give participants one of two recommended doses identified earlier, either alone or combined with standard treatments. Treatments are given in 21-day cycles and continue until the cancer worsens, side effects become unacceptable, or other reasons for stopping occur. The adaptive design allows for modifying treatment groups or stopping early based on effectiveness or safety. Participants will be closely monitored with regular assessments including physical exams, vital signs, heart rate, blood pressure, ECGs, laboratory tests, and performance status evaluations. Safety is carefully evaluated in the first 21-day cycle for serious adverse events and dose-limiting toxicities. The study tracks participants until disease progression, withdrawal, or loss to follow-up. The trial runs until October 2027, aiming to provide detailed safety and dosing information for KESONOTIDE12 in solid tumors.

Early Phase Study of KESONOTIDE™in Participants With Solid Tumours