Experimental combo aims to tackle Hard-to-Treat prostate cancer
NCT ID NCT05743621
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests a new drug called TVB-2640 combined with the standard drug enzalutamide (Xtandi) in 30 men whose prostate cancer has spread and stopped responding to hormone therapy. The main goal is to find the safest dose of TVB-2640 when used with enzalutamide and to track any side effects. Participants will be followed for about 12 to 24 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TVB-2640 (a fatty acid synthase inhibitor) combined with enzalutamide (Xtandi)
- What this could lead to
- If this combination proves safe, it could lead to a new treatment option for men with advanced prostate cancer that has stopped responding to hormone therapy.
- What could go wrong
- This is a very early Phase 1 trial with only 30 participants, focused on safety and dosing. It is too small and early to know if the combination actually works against cancer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2023
- Expected to finish
-
Jan 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age \>18 years * Documented histological or cytological diagnosis of PC * Evidence of metastatic PC on imaging (bone scan and/or CT/MRI scan) * Diagnosis of progressive metastatic, castration resistant prostate cancer * Potential participant must be planning to receive Enzalutamide as their first line of therapy for castration resistant prostate cancer or have previously received up to one line of Abiraterone or an androgen receptor antagonist * Willing to undergo a tumor biopsy prior to beginning therapy, if recent tissue samples are not available * Willing to undergo a tumor biopsy of at least one metastatic site or primary prostate after \~4-6 weeks of therapy with both agents * Participants without prior orchiectomy must be currently taking and willing to continue luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist) therapy until permanent discontinuation of study treatment * ECOG performance status of 0-1 * Recovery to baseline or ≤ Grade 1 CTCAE v5 from toxicities related to any prior treatments, unless specified below AE(s) are clinically nonsignificant and/or stable on supportive therapy * Adequate organ and marrow function, based upon laboratory criteria within 14 days before first dose of study treatment * Sexually active, fertile participants and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom with spermicide during the course of the study and for 4 months after the last dose of study treatment * Capable of understanding and complying with the protocol requirements and must have signed the informed consent document Exclusion Criteria: * Receipt of any type of biologic, or other systemic anticancer therapy (including investigational) except agents within 4 weeks before first dose of study treatment. Anti-resorptive bone agents are also allowed. * Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment. Participants with clinically relevant ongoing complications from prior radiation therapy are not eligible. * Prior exposure to taxane chemotherapy * History of pneumonitis * Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment after radiotherapy or at least 4 weeks prior to first dose of study treatment after major surgery (e.g., removal or biopsy of brain metastasis). Participants must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Eligible participants must be neurologically asymptomatic and without corticosteroid treatment for neurological indications at the time of first dose of study treatment. * Participants with clinically significant dry eye or corneal abnormalities * Currently taking certain anticoagulation medications, such as coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel) * Participant has prothrombin time (PT)/INR or partial thromboplastin time (PTT) test ≥ 1.3 X the laboratory ULN within 30 days before the first dose of study treatment. * Participants should not receive strong CYP2C8 or strong P-gp inhibitors; strong CYP3A4 or CYP2C8 inducers; and strong CYP3A4, CYP2C9 and CYP2C19 substrates while participating in the trial, unless utilized with caution to treat a drug-related AE when no alternative is available and discussed with the Medical Monitor. * Participant has uncontrolled, significant intercurrent or recent Cardiovascular disorders including, but not limited to, the following conditions: i. Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias. ii. Uncontrolled hypertension defined as sustained blood pressure (BP) \>140 mm Hg systolic or \>90 mm Hg diastolic despite optimal antihypertensive treatment. iii. Stroke (including transient ischemic attack \[TIA\]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (e.g. deep venous thrombosis, pulmonary embolism) within 6 months before first dose. * Corrected QT interval calculated by the Fridericia formula (QTcF) \> 470 ms per electrocardiogram (ECG) within 28 days before first dose of study treatment. * Inability to swallow tablets. * Use of herbal products that may decrease PSA levels within 4 weeks prior to enrollment * Previously identified allergy or hypersensitivity to components of the study treatment formulations. * Diagnosis of another type of cancer within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. * Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Prostatic neoplasms, castration-resistant are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Weill Cornell Medicine/NewYork-Presbyterian Hospital
RECRUITINGNew York, New York, 10021, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- What drives survival in advanced prostate cancer? a brazilian study digs into patient data
- Can a new daily pill slow advanced prostate cancer?
- Radiation plus hormone therapy may slow resistant prostate cancer
- Real-World data may reveal Pluvicto's true impact on advanced prostate cancer survival
- Mapping the next steps: how men with advanced prostate cancer are treated after standard therapies fail
- Massive data dive aims to uncover best prostate cancer treatments in real life