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Prostate CancerPhase 1/2NCT06457919

A Study of Tinengotinib (TT-00420) in Combination With Standard Treatments in People With Prostate Cancer

A Phase 1/2 study testing Tinengotinib, abiraterone acetate with prednisone and Enzalutamide in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 12 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Tinengotinib, abiraterone acetate with prednisone and Enzalutamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
12 sitesUnited States
Study dates
4 Jun 2024to Jun 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Wassim Abida, MD, PhD contact

646-442-4633

abidam@mskcc.org

Michael Morris, MD contact

646-422-4469

12 sites in 1 country

United States12 sites, 12 recruiting

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920

    Wassim Abida, MD, PhD, 646-442-4633

    Recruiting

  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

    Commack, New York, 11725

    Wassim Abida, MD, PhD, 646-442-4633

    Recruiting

  • Duke University

    Durham, North Carolina, 27710

    Hannah Dzimitrowicz McManus, MD, 919-668-6688

    Recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604

    Wassim Abida, MD, PhD, 646-442-4633

    Recruiting

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748

    Wassim Abida, MD, PhD, 646-442-4633

    Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

    Wassim Abida, MD, PhD, 646-442-4633

    Recruiting

  • Yale University (Data Collection Only)

    New Haven, Connecticut, 06511

    Samir Zaidi, MD, PhD, samir.zaidi@yale.edu

    Recruiting

  • Columbia University

    New York, New York, 10032

    Mark Stein, MD, 212-305-5098

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Wassim Abida, MD, PhD, 646-442-4633

    Michael Morris, MD, 646-422-4469

    Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Raghava Levaka, MD, 215-890-3030

    Not yet recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Eleni Efstathiou, MD, 503-494-6594

    Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553

    Wassim Abida, MD, PhD, 646-442-4633

    Recruiting

Other trials in United States

About this study

Official title: 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)

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
Being tested
Tinengotinib, abiraterone acetate with prednisone, Enzalutamide
Keywords
Tinengotinib (TT-00420), Androgen Receptor Signaling Inhibitors (ARSIs), TIP Study: Tinengotinib In Prostate Cancer, Prostate Cancer Clinical Trials Consortium, LLC (PCCTC), 24-103
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TinengotinibDrug

    Also called TT-00420

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

  • abiraterone acetate with prednisoneDrug

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

  • EnzalutamideDrug

    Enzalutamide 160 mg PO QD

Study groups in NCT06457919
Study groupRoleWhat they receive
Tinengotinib with abiraterone acetate/prednisoneExperimentalTinengotinib 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)
Receives: Drug: Tinengotinib; Drug: abiraterone acetate with prednisone
Tinengotinib with enzalutamideExperimentalTinengotinib 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.
Receives: Drug: Tinengotinib; Drug: Enzalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RP2D

    Evaluate DLT occurrence to confirm safety and RP2D

    Measured: From the start of study treatment through the DLT window (28 days)

  2. Objective Response Rate (ORR)

    by local investigator's assessment per PCWG3-modified RECIST v1.1 in participants with baseline measurable disease OR rate of PSA decline of ≥ 50% from baseline in patients with a baseline PSA of 2.0 ng/mL or above

    Measured: up to 6months

Secondary outcomes (1)

  1. Rate of Radiographic Response (phase II)

    Rate of radiographic response by local investigator's assessment per PCWG3-modified RECIST v1.1 in participants with baseline measurable disease

    Measured: From start of study treatment until 6 months post study treatment start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2024
  2. Study start4 Jun 2024
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
In the Phase 1b portion of the study, participants will be enrolled sequentially in cohorts of 3 for each studied combination. The recommended Phase II dose (RP2D) of each combination will be estimated separately based on the de-escalation rules.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06457919
Sponsor's protocol ID
24-103
Status last verified
Jun 2026
First submitted
5 Jun 2024
Last updated
25 Jun 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Tinengotinib, abiraterone acetate with prednisone and Enzalutamide in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wassim Abida, MD, PhD (646-442-4633, abidam@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RP2D (time frame: From the start of study treatment through the DLT window (28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06457919.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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