Prostate Cancer study: Tinengotinib vs Enzalutamide
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 oral medicine being studied for metastatic castration‑resistant prostate cancer.
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 study aims to see if tinengotinib combined with abiraterone acetate and prednisone or enzalutamide is safe and causes few or mild side effects in people with metastatic castration‑resistant prostate cancer.
- Who it's for
- Men with metastatic castration‑resistant prostate cancer
- What's involved
- Participants will receive tinengotinib together with either abiraterone acetate and prednisone or enzalutamide, and will have regular visits and tests to monitor safety.
- Time commitment
- The study lasts several months and requires multiple clinic visits for medication administration and safety monitoring.
- 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...
- 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...
You likely can't join if
- 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.
- Symptomatic and/or untreated CNS metastases.
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).
- 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.
- 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
- 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
- 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...
- 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.
- 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
- Palliative radiation within 2 weeks of study treatment start.
The study team makes the final eligibility decision.
Where it is enrolling
- 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
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, but 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?
This study is enrolling now at 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 4 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.