OncoMatch/Clinical Trials/NCT06457919
A Study of Tinengotinib (TT-00420) in Combination With Standard Treatments in People With Prostate Cancer
Is NCT06457919 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Tinengotinib and abiraterone acetate with prednisone for prostate cancer.
Treatment: Tinengotinib · abiraterone acetate with prednisone · Enzalutamide — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: antiandrogen (abiraterone acetate, enzalutamide) — current ongoing therapy at full standard dose, started at least 90 days before screening, interruption of max 30 days permitted
Current ongoing therapy and observed tolerance with full standard dose of abiraterone acetate (1000 mg QD) or enzalutamide (160 mg QD) at the time of study entry...Progressive disease on enzalutamide or abiraterone acetate documented by PCWG3 criteria for study entry.
Must have received: androgen deprivation therapy — medically or surgically castrated with ongoing ADT for ≥90 days or history of bilateral orchiectomy
Participants must be medically or surgically castrated with ongoing androgen deprivation therapy (ADT) for ≥90 days or have documented history of bilateral orchiectomy.
Cannot have received: multi-TKI therapies
Previous exposure to multi-TKI therapies.
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 × 10^9 /L; Hemoglobin ≥ 9 g/dL; Platelets ≥ 75 × 10^9 /L
Kidney function
Creatinine clearance >30 mL/min (Cockcroft-Gault formula)
Liver function
AST/SGOT and ALT/SGPT ≤ 2.5 × ULN or ≤ 5.0 × ULN if liver metastases are present; Total bilirubin ≤ 1.5 × ULN; or < 2.5 × ULN if Gilbert syndrome or disease involving liver
Cardiac function
Adequate blood coagulation function as evidenced by INR ≤ 1.5 unless participant is on anticoagulants
Adequate organ function confirmed at screening, as evidenced by: Absolute neutrophil count ≥ 1.5 × 10^9 /L; Hemoglobin ≥ 9 g/dL; Platelets ≥ 75 × 10^9 /L; AST/SGOT and ALT/SGPT ≤ 2.5 × ULN or ≤ 5.0 × ULN if liver metastases are present; Total bilirubin ≤ 1.5 × ULN; or < 2.5 × ULN if Gilbert syndrome or disease involving liver; Creatinine clearance >30 mL/min (Cockcroft-Gault formula); Adequate blood coagulation function as evidence by an international normalized ratio (INR) ≤ 1.5 unless participant is on anticoagulants
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Yale University (Data Collection Only) · New Haven, Connecticut
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) · Commack, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify