Actively Recruiting
A Study of Tinengotinib (TT-00420) in Combination With Standard Treatments in People With Prostate Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-24
50
Participants Needed
12
Research Sites
156 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
T
TransThera Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study of Tinengotinib (TT-00420) in Combination With Standard Treatments in People With Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants 18 years or older with signed informed consent
- Histologically confirmed prostate carcinoma (neuroendocrine allowed; pure small cell carcinoma excluded)
- Metastatic disease with at least 2 bone lesions on radionuclide bone scan or soft tissue disease on CT/MRI
- Receiving full standard dose of abiraterone acetate (1000 mg QD) or enzalutamide (160 mg QD) for at least 90 days before screening
- Progressive disease on enzalutamide or abiraterone acetate documented by PCWG3 criteria
- At least one of: measurable soft tissue tumor lesions or PSA of 2.0 ng/mL or above at baseline
- Medically or surgically castrated with ongoing androgen deprivation therapy for 90 days or history of bilateral orchiectomy
- ECOG performance status 0 to 2
- Adequate organ function confirmed by blood counts, liver enzymes, bilirubin, creatinine clearance, and blood coagulation
- Tumor biopsy during screening if safe and feasible; archival tissue acceptable if recent
You will not qualify if you...
- Pure small cell carcinoma
- Previous exposure to multi-TKI therapies
- Uncontrolled hypertension or known coronary artery disease with angina
- History of congestive heart failure Class II-IV or serious cardiac arrhythmia requiring treatment
- Myocardial infarction within 6 months before study entry
- QTc interval >480 msec at screening unless pacemaker present
- Prior or concurrent malignancy interfering with study assessments
- Symptomatic or untreated CNS metastases
- Pre-existing duodenal stent or gastrointestinal conditions affecting medication absorption
- Requirement for corticosteroids >10 mg prednisone equivalent within 14 days before treatment
- Other anticancer therapies within 3 weeks or 5 half-lives before treatment, except ADT, enzalutamide, or abiraterone acetate
- Palliative radiation within 2 weeks before treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Yale University (Data Collection Only)
New Haven, Connecticut, United States, 06511
Actively Recruiting
2
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
3
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
4
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
5
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
6
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
7
Columbia University
New York, New York, United States, 10032
Actively Recruiting
8
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
9
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
10
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
11
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
12
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Not Yet Recruiting
Research Team
W
Wassim Abida, MD, PhD
CONTACT
M
Michael Morris, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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