Recruiting
Phase 1
Phase 2

Tinengotinib & Standard Treatments

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06457919

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tinengotinib

abiraterone acetate with prednisone

Enzalutamide

Study Details

Brief summary:

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

Prostate Cancer

Study ID

NCT06457919

Start date

Jun 4, 2024

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tinengotinib with abiraterone acetate/prednisone

Tinengotinib will be administered daily for 28-day cycles. A flat dose of 10 mg PO once daily will be administered unless dose de-escalation is required in Phase 1b. Participants will receive tinengotinib with abiraterone acetate 1000 mg PO QD in combination with prednisone 5 mg PO once or twice daily (QD or BID)

experimental: Tinengotinib with enzalutamide

Tinengotinib will be administered daily for 28-day cycles. A flat dose of 10 mg PO once daily will be administered unless dose de-escalation is required in Phse 1b. Participants will receive Tinengotinib in combination with enzalutamide 160 mg PO QD.

Interventions

Tinengotinib

Tinengotinib will be administered daily for 28-day cycles. A flat dose of 10 mg PO once daily.

abiraterone acetate with prednisone

Abiraterone acetate 1000 mg PO QD in combination with prednisone 5 mg PO once or twice daily (QD or BID)

Enzalutamide

Enzalutamide 160 mg PO QD

Primary outcome measure

  • RP2D [ Time Frame: From the start of study treatment through the DLT window (28 days) ]
  • Objective Response Rate (ORR) [ Time Frame: up to 6months ]

Central Contacts and Locations

Central contacts

Wassim Abida, MD, PhD

646-442-4633abidam@mskcc.org

Michael Morris, MD

646-422-4469

Locations

Yale University (Data Collection Only)

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

Samir Zaidi, MD, PhD

samir.zaidi@yale.edu

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Wassim Abida, MD, PhD

646-442-4633

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Wassim Abida, MD, PhD

646-442-4633

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Wassim Abida, MD, PhD

646-442-4633

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Wassim Abida, MD, PhD

646-442-4633

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Wassim Abida, MD, PhD

646-442-4633

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Mark Stein, MD

212-305-5098

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Wassim Abida, MD, PhD

646-442-4633

Michael Morris, MD

646-422-4469

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Wassim Abida, MD, PhD

646-442-4633

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Hannah Dzimitrowicz McManus, MD

919-668-6688

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Eleni Efstathiou, MD

503-494-6594

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

  • Tinengotinib (TT-00420)
  • Androgen Receptor Signaling Inhibitors (ARSIs)
  • TIP Study: Tinengotinib In Prostate Cancer
  • Prostate Cancer Clinical Trials Consortium, LLC (PCCTC)
  • 24-103

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-06-25.