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Combining Tinengotinib with Standard Treatments for Prostate Cancer

A Phase 1b/2 Study Evaluating the Activity of Tinengotinib (TT-00420) in Combination With Androgen Receptor Signaling Inhibitors (ARSIs) in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

Phase1; Phase2 Interventional Memorial Sloan Kettering Cancer Center · NCT06457919

This study is testing if adding tinengotinib to standard prostate cancer treatments can help men with advanced prostate cancer feel better and improve their outcomes.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment50 (estimated)
Ages18 Years and up
SexMale
SponsorMemorial Sloan Kettering Cancer Center Academic / other
Drugs / interventionsradiation, prednisone, tinengotinib
Locations12 sites (New Haven, Connecticut and 11 other locations)
Trial IDNCT06457919 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and side effects of tinengotinib when used alongside standard treatments like abiraterone acetate and prednisone or enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC). Participants must have confirmed prostate cancer and show tolerance to standard doses of the mentioned treatments. The study aims to determine if this combination can provide a more effective treatment option for patients with progressive disease.

Who should consider this trial

Good fit: Ideal candidates are adult males aged 18 and older with confirmed metastatic castration-resistant prostate cancer who have tolerated standard doses of abiraterone acetate or enzalutamide.

Not a fit: Patients who are intolerant to standard doses of abiraterone acetate or enzalutamide will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new, safer option for patients with advanced prostate cancer.

How similar studies have performed: Other studies have shown promise in combining novel agents with standard treatments for prostate cancer, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion 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 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:

  1. 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.
  2. Nodal or visceral progression as defined by PCWG3-modified RECIST 1.1
  3. Appearance of 2 or more new lesions on a bone scan
* At least one of the following at study entry:

  1. 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
  2. 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 safe and feasible. If neither option is possible, archival tissue from any timepoint should be requested, if available.

Exclusion Criteria:

* 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.

Where this trial is running

New Haven, Connecticut and 11 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Prostate CancerTinengotinibAndrogen Receptor Signaling InhibitorsTIP Study: Tinengotinib In Prostate CancerProstate Cancer Clinical Trials Consortium, LLC24-103
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.