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New treatment option for Prostate Cancer
Official title A Study of Tinengotinib (TT-00420) in Combination With Standard Treatments in People With Prostate Cancer
ClinicalTrials.gov ID: NCT06457919
What this study is testing
What is Tinengotinib?
Tinengotinib is an investigational medicine, given as an once-daily, being studied as a potential treatment for prostate cancer.
Also referred to as TT-00420.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- 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...
- Progressive disease on enzalutamide or abiraterone acetate documented by PCWG3 criteria for study entry. Progressive disease is defined as at least...
You likely can't join if
- 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...
- History of congestive heart failure of Class II-IV New York Heart Association criteria, or serious cardiac arrhythmia requiring treatment (except...
- Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessments.
See the full eligibility 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...
- 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...
- 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:
- PSA progression defined as a minimum of 2 rising PSA levels with a minimum of a 1-week interval between each determination, reaching a minimum PSA value of 1.0 ng/mL.
- Nodal or visceral progression as defined by PCWG3-modified RECIST 1.1
- Appearance of 2 or more new lesions on a bone scan
- At least one of the following at study entry:
- RECIST 1.1 measurable disease at baseline; i.e., soft tissue tumor lesions or pathologically enlarged lymph nodes that can be accurately measured in at least one dimension OR
- a PSA of 2.0 ng/mL or above
- 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...
- 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...
- 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...
- Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works 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...
- Palliative radiation within 2 weeks of study treatment start.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
- Durham, North Carolina, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.