A Study of Tinengotinib for Prostate Cancer
This study is looking into a new treatment for metastatic castration-resistant prostate cancer (mCRPC), which is prostate cancer that has spread and no longer responds to standard hormone therapy. Researchers want to see if combining a drug called tinengotinib with either abiraterone acetate and prednisone, or enzalutamide, is safe and causes few side effects. They will also look at how many participants respond to the treatment. You may be able to join if you are an adult male with prostate cancer that has spread. The study plans to enroll about 50 people, but its current recruitment status is unclear.
- Study design
- This interventional study is testing tinengotinib in combination with standard treatments. It aims to enroll about 50 participants.
- What's involved
- You would receive tinengotinib daily for 28-day cycles, along with either abiraterone acetate and prednisone, or enzalutamide. The study will assess safety and side effects for at least 28 days, and treatment response for up to 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure treatment response for up to 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06457919
A Study of Tinengotinib (TT-00420) in Combination With Standard Treatments in People With Prostate Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~50 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:Tinengotinibabiraterone acetate with prednisoneEnzalutamide
At a glance
Recruiting sites
11 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
RP2D
Measured over From the start of study treatment through the DLT window (28 days)
+1 more outcome measured
Conditions
Where it's being run
12 sites across 6 statesNew York5
New Jersey3
Connecticut1
North Carolina1
Oregon1
Pennsylvania1
Study leadership
- Wassim Abida, MD, PhD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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) or enzalutamide (160 mg QD) at the time of study entry. Enzalutamide or abiraterone acetate must have been started at least 90 days before screening assessments. An interruption of dosing of a maximum of 30 days is permitted prior to resuming the agent. Please note: Patients who are on a reduced dose or are intolerant of abiraterone acetate or enzalutamide at screening will not be eligible for study participation.
Progressive disease on enzalutamide or abiraterone acetate documented by PCWG3 criteria for study entry. Progressive disease is defined as at least one of the following:
At least one of the following at study entry:
Participants must be medically or surgically castrated with ongoing androgen deprivation therapy (ADT) for ≥90 days or have documented history of bilateral orchiectomy.
ECOG 0 - 2
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
Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 2.5 × upper limit of normal (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
Tumor biopsy during screening is required if safe and feasible. If archival tissue is available from a previous biopsy performed within 90 days of screening assessments, a repeat screening biopsy is not required even if safe and feasible. If neither option is possible, archival tissue from any timepoint should be requested, if available.
Exclusion
The presence of any of the following criteria excludes a patient from participating in the study:
Pure small cell carcinoma
Previous exposure to multi-TKI therapies.
Uncontrolled hypertension (persistent systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg) or known coronary artery disease with angina. Patients with known hypertension must be on antihypertensive medication with BPs generally \<140/90 to be eligible.
History of congestive heart failure of Class II-IV New York Heart Association criteria, or serious cardiac arrhythmia requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 6 months of study entry, or prolongation of QTc interval to \>480 msec using Fridericia formula (QTcF) at screening (except for participants with pacemakers, where there is no QTc cutoff).
Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessments.
Symptomatic and/or untreated CNS metastases.
Pre-existing duodenal stent or any gastrointestinal disorder or defect which would interfere with absorption of study medication, as determined by the Investigator.
Persistent requirement for corticosteroids at equivalent of \>10 mg QD prednisone within 14 days before study treatment start.
Other anticancer therapies within 3 weeks of study treatment start, or within 5 half-lives of study treatment start for non-cytotoxic oral agents, whichever is shorter; with the exception of androgen deprivation therapy, enzalutamide, or abiraterone acetate which should be continued through study treatment.
Palliative radiation within 2 weeks of study treatment start.
What this trial measures
- RP2DFrom the start of study treatment through the DLT window (28 days)
Evaluate DLT occurrence to confirm safety and RP2D
- Objective Response Rate (ORR)up to 6months
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