Memorial Sloan Kettering Cancer Center
The purpose of this study is to find out whether tinengotinib in combination with abiraterone acetate and prednisone or enzalutamide is a safe treatment that causes few or mild side effects in people with metastatic castration-resistant prostate cancer (mCRPC).
Inclusion Criteria: * Participants ≥ 18 years old, with signed informed consent * Histologically confirmed carcinoma of the prostate (neuroendocrine differentiation is allowed, but pure small cell carcinoma is not permitted) * Metastatic disease documented by at least 2 bone lesions on whole body radionuclide bone scan, or soft tissue disease documented by computed tomography (CT) scan/magnetic resonance imaging (MRI). Note: Metastatic disease seen only on PET imaging does not qualify. * Current ongoing therapy and observed tolerance with full standard dose of abiraterone acetate (1000 mg QD)…
Tinengotinib will be administered daily for 28-day cycles. A flat dose of 10 mg PO once daily.
Abiraterone acetate 1000 mg PO QD in combination with prednisone 5 mg PO once or twice daily (QD or BID)
Enzalutamide 160 mg PO QD