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

NCT06347705 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 23-252
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 7

Brief 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. 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

Keywords

Prostate Cancer; 2141-V11; Memorial Sloan Kettering Cancer Center; 23-352

Outcome Measures

Primary Outcomes (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.

  24 months

Study Arms (2)

Cohort B

EXPERIMENTAL

Men presenting with clinically localized or locoregional high-risk disease.

Biological: 2141-V11 Antibody

Cohort C

EXPERIMENTAL

Men presenting with low-volume metastatic disease for whom a multimodality therapeutic approach including removal of the primary has the potential to eliminate all disease.

Biological: 2141-V11 Antibody

Interventions

2141-V11 Antibody BIOLOGICAL

2141-V11 Antibody: Intratumor injection

Cohort B; Cohort C

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All protocol activites)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Matthew Dallos, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Dallos, MD

CONTACT

646-888-4716; dallosm@mskcc.org

Karen Autio, MD

CONTACT

646-422-4448; autiok@mskcc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: March 28, 2024
• Primary Completion (Estimated): March 28, 2029
• Study Completion (Estimated): March 28, 2029
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (7)