A Study of 2141-V11 for Prostate Cancer
This study is looking at a new treatment approach for prostate cancer. It combines a drug called 2141-V11 Antibody with standard treatments. 2141-V11 works by helping your immune system find and kill cancer cells. Researchers want to see if this combination can completely get rid of cancer or leave only a very small amount of cancer cells (minimal residual disease or MRD). You may be able to join if you are a man aged 18 or older with prostate cancer and a certain testosterone level. The study aims to enroll 57 participants, but its current status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 57 participants. The specific phase of the study is not mentioned.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will measure the study's success at 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06347705
A Study of 2141-V11 in Combination With Standard Treatments in People With Prostate Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~57 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested:2141-V11 Antibody
At a glance
Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with a complete response or minimal residual disease.
Measured over 24 months
Conditions
Where it's being run
7 sites across 2 statesNew York4
New Jersey3
Study leadership
- Matthew Dallos, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization) NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
Male aged 18 years and above
Serum testosterone of ≥150 ng/dL except for patients currently on ADT.
Adequate bone marrow, hepatic, and renal function, as evidenced within 28 days prior to treatment start by:
Participants must have a clinical T stage documented by the treating urologist/medical oncologist within 90 days prior to treatment start using the 8th edition American Joint Committee on Cancer (AJCC) staging system, recorded as the urologist's/medical oncologist's best clinical assessment of extent of local disease by digital rectal examination and/or available imaging studies such as transrectal ultrasound, CT scan, and/or MRI.
Candidate for RP with lymph node dissection as per the investigator
Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug.
Evidence of a prostate lesion on prostate magnetic resonance imaging scan
Prior prostate cancer metastasis-directed therapies other than described above.
Currently active second malignancy or past medical history of malignancies diagnosed within the last 5 years that require active therapy and/or in remission with life expectancy of \< 5 years, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I head and neck cancer, or stage I colorectal cancer.
Significant medical condition other than cancer, that would prevent consistent and compliant participation in the study that would, in the opinion of the investigator, make this protocol unreasonably hazardous including but not limited to:
Any medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone once daily
Active infection requiring systemic therapy
History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents
Uncontrolled hypertension (systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 95 mmHg); participants with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment (systolic BP \<160 mmHg or diastolic BP \<95 mmHg)
Acute or chronic hepatitis B or hepatitis C infection. (Hepatitis B and C testing are not mandatory)
Presence of hepatitis B surface antibody is acceptable
Baseline moderate and severe hepatic impairment (Child Pugh Class B \& C)
Human immunodeficiency virus (HIV)-positive participants with 1 or more of the following:
Not receiving highly active anti-retroviral therapy.
A change in anti-retroviral therapy within 6 months of the start of screening (except if, after consultation with the principal investigator (PI) / sponsor, a change is made to avoid a potential drug-drug interaction with the study drug).
Receiving anti-retroviral therapy that may interfere with the study drug(s) (consult the PI / sponsor for review of medication prior to enrollment).
CD4 count \< 350 cell/mm3 at screening.
An acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screening.
HIV testing is not mandatory
History of pituitary or adrenal dysfunction
Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or cardiac ejection fraction measurement of \< 50% at baseline, or clinically significant ventricular arrhythmias within 6 months prior to treatment start.
History of seizure or any condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness
History of an inflammatory bowel disease (Crohn's or ulcerative colitis)
Any additional medications that investigators are concerned will affect the response to immunotherapy.
Use of any prohibited concomitant medications precluding safe treatment with ADT or an ARSI within 14 days prior to treatment start.
Known allergies, hypersensitivity or intolerance to apalutamide, enzalutamide, daralutamide or GNRH agonist or GNRH antagonist
Participants that cannot tolerate MRI
For cohort B, clinically significant symptoms related to local or metastatic disease.
Exclusion
Prior prostate surgery, pelvic lymph node dissection, radiation therapy, or focal therapy as a treatment for prostate cancer or benign prostatic disease.
Current ADT with GnRH antagonist/agonist and/or ARSI initiated \>12 weeks enrollment.
Prior cytotoxic chemotherapy for prostate cancer
Prior experimental therapy for prostate cancer within 30 days of planned Cycle 1 of 2141-V11.
What this trial measures
- Number of participants with a complete response or minimal residual disease.24 months
To determine the proportion of patients in each cohort in whom a pathologic complete response (pCR) or minimal residual disease (pMRD, ≤ 5mm tumor) is observed in the resected primary tumor.