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Prostate CancerPhase 2NCT06347705

A Study of 2141-V11 in Combination With Standard Treatments in People With Prostate Cancer

A Phase 2 study testing 2141-V11 Antibody in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 7 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 see whether combining 2141-V11 with various standard treatments is an effective treatment approach for prostate cancer. 2141-V11 works by activating the immune system to find and kill cancer cells. 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?
2141-V11 Antibody
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
7 sitesUnited States
Study dates
28 Mar 2024to 28 Mar 2029
Phase
Phase 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

  • 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:
  • ANC ≥1500/µl (≥1000/µl if benign ethnic neutropenia) Hemoglobin ≥9 g/dL Platelet count ≥100,000/µl Creatinine Clearance Measure by Cockcroft-Gault Formula >45 mL/min Total Bilirubin ≤ 1.8 mg/dl (Note: In participants with Gilbert's syndrome, if total bilirubin is 1.8 mg/dL, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, participant may be eligible) SGOT (AST) ≤ 92.5 U/L SGPT (ALT) ≤ 137 U/L
  • 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.
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  • 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

Who cannot join

  • Participants that meet any of the criteria listed below will not be eligible for study entry:
  • 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.
  • Known brain, liver, lung or other visceral metastasis (with the exception of retroperitoneal and / or pelvic nodal metastases as per inclusion criteria)
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  • 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
  • ≤1 year prior to treatment start; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
  • 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.
  • Note: Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks 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.

Trial locations and contacts

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

Matthew Dallos, MD contact

646-888-4716

dallosm@mskcc.org

Karen Autio, MD contact

646-422-4448

autiok@mskcc.org

7 sites in 1 country

United States7 sites, 7 recruiting

  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920

    Matthew Dallos, MD, 646-888-4716

    Recruiting

  • Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

    Commack, New York, 11725

    Matthew Dallos, MD, 646-888-4716

    Recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604

    Matthew Dallos, MD, 646-888-4716

    Recruiting

  • Memorial Sloan Kettering Monmouth (Limited protocol activities)

    Middletown, New Jersey, 07748

    Matthew Dallos, MD, 646-888-4716

    Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

    Matthew Dallos, MD, 646-888-4716

    Recruiting

  • Memorial Sloan Kettering Cancer Center (All protocol activites)

    New York, New York, 10065

    Matthew Dallos, MD, 646-888-4716

    Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activites)

    Rockville Centre, New York, 11553

    Matthew Dallos, MD, 646-888-4716

    Recruiting

Other trials in United States

About this study

Official title: Phase II Study Evaluating the Effects of Single Site Intratumoral Injections of Anti-CD40 Agonist Antibody (2141-V11) Given as Monotherapy Prior to Radical Prostatectomy to Men With Intermediate Risk Disease and in Combination With Androgen Deprivation Therapy for Those With High Risk Localized and Low Volume Metastatic Disease

The purpose of this study is to see whether combining 2141-V11 with various standard treatments is an effective treatment approach for prostate cancer. 2141-V11 works by activating the immune system to find and kill cancer cells. Researchers will look at whether this treatment approach is able to completely get rid of cancer in participants, and they will check for the presence of minimal residual disease (MRD) in participants. MRD is a small number of cancer cells that can be detected in the body after treatment.

Conditions
Prostate Cancer
Being tested
2141-V11 Antibody
Keywords
Prostate Cancer, 2141-V11, Memorial Sloan Kettering Cancer Center, 23-352
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • 2141-V11 AntibodyBiological

    2141-V11 Antibody: Intratumor injection

Study groups in NCT06347705
Study groupRoleWhat they receive
Cohort BExperimentalMen presenting with clinically localized or locoregional high-risk disease.
Receives: Biological: 2141-V11 Antibody
Cohort CExperimentalMen presenting with low-volume metastatic disease for whom a multimodality therapeutic approach including removal of the primary has the potential to eliminate all disease.
Receives: Biological: 2141-V11 Antibody

What is being measured

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

  1. Number of participants with a complete response or minimal residual disease.

    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.

    Measured: 24 months

Timeline

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

  1. First posted4 Apr 2024
  2. Study start28 Mar 2024
  3. Primary completion28 Mar 2029 (estimated)
  4. Study completion28 Mar 2029 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
57 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06347705
Sponsor's protocol ID
23-252
Status last verified
Apr 2026
First submitted
29 Mar 2024
Last updated
16 Apr 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 2 study testing 2141-V11 Antibody in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 7 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 9 inclusion and 34 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 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 phase mean?

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 Matthew Dallos, MD (646-888-4716, dallosm@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with a complete response or minimal residual disease. (time frame: 24 months). 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 NCT06347705.

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 16 Apr 2026.

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