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New treatment option for Prostate Cancer
Official title A Study of 2141-V11 in Combination With Standard Treatments in People With Prostate Cancer
ClinicalTrials.gov ID: NCT06347705
What this study is testing
What is 2141-V11 Antibody?
2141-V11 Antibody is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA...
- 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...
- Participants must have a clinical T stage documented by the treating urologist/medical oncologist within 90 days prior to treatment start using the...
You likely can't join 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...
- 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...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- Evidence of a prostate lesion on prostate magnetic resonance imaging scan
- 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)
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.