RecruitingPhase 1/2

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

United States50 participantsStarted 2024-06-04

Plain-language 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).

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

RP2D

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

Objective Response Rate (ORR)

Timeframe: up to 6months

Trial details

NCT IDNCT06457919

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Wassim Abida, MD, PhD

646-442-4633 abidam@mskcc.org

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