A Study of Tinengotinib (TT-00420) in Combination With Standard Treatments in People With Prostate Cancer, TIP Trial

This phase Ib/II trial tests the safety, side effects, best dose, and effectiveness of tinengotinib (TT-0420) in combination with abiraterone acetate and prednisone or enzalutamide in treating patients with prostate cancer that continues to grow despite efforts to block male hormones (castration resistant) and has spread from where it first started to other places in the body (metastatic). Tinengotinib, a multi-target kinase inhibitor, works by attaching to and blocking several different proteins that send signals to tumor cells to grow. By blocking these proteins, tinengotinib may help slow or stop the growth of tumor cells. Abiraterone acetate decreases the activity of reproductive hormones (androgens). Androgens stimulate prostate tumor cells to grow. By decreasing the activity of androgens, abiraterone acetate may help slow or stop the growth of tumor cells. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response and is given with abiraterone acetate to reduce or prevent some of the side effects of abiraterone acetate. Enzalutamide is a type of drug called an androgen receptor inhibitor. It works by blocking the effects of androgen, which helps stop the growth and spread of tumor cells. Giving tinengotinib in combination with abiraterone acetate and prednisone or with enzalutamide may be safe, tolerable and/or effective in treating patients with metastatic castration-resistant prostate cancer.