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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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
Yale University (Data Collection Only)
New Haven, Connecticut, United States
RECRUITINGMemorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
RP2D
Evaluate DLT occurrence to confirm safety and RP2D
Time frame: From the start of study treatment through the DLT window (28 days)
Objective Response Rate (ORR)
by local investigator's assessment per PCWG3-modified RECIST v1.1 in participants with baseline measurable disease OR rate of PSA decline of ≥ 50% from baseline in patients with a baseline PSA of 2.0 ng/mL or above
Time frame: up to 6months
Rate of Radiographic Response (phase II)
Rate of radiographic response by local investigator's assessment per PCWG3-modified RECIST v1.1 in participants with baseline measurable disease
Time frame: From start of study treatment until 6 months post study treatment start
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Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States
RECRUITINGMemorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
RECRUITINGColumbia University
New York, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGMemorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States
RECRUITINGDuke University
Durham, North Carolina, United States
RECRUITING...and 2 more locations