2141-V11 Antibody for Prostate Cancer

Phase 2

Recruiting

Led By Matthew Dallos, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test whether adding 2141-V11 to standard prostate cancer treatments is effective. 2141-V11 activates the immune system to target and destroy cancer cells. Researchers will assess if

Who is the study for?

Men over 18 with prostate cancer who have not had certain treatments or surgeries for it. They must be able to consent, have a targetable lesion on MRI, and agree to use contraception if sexually active. Excluded are those with recent experimental therapy, significant heart disease, inability to undergo MRI, known metastases in specific organs, inflammatory bowel disease, HIV under certain conditions, seizure risks, severe allergies or liver impairment.

What is being tested?

The trial is testing the effectiveness of a new antibody called 2141-V11 when combined with standard prostate cancer treatments. It aims to activate the immune system against cancer cells and will measure success by checking for minimal residual disease – tiny amounts of cancer that might remain after treatment.

What are the potential side effects?

While specific side effects of 2141-V11 aren't listed here, similar immune-activating antibodies can cause reactions like flu-like symptoms (fever/chills), fatigue, allergic responses at infusion sites and potentially affect organ function due to an overactive immune response.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort CExperimental Treatment1 Intervention

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.

Group II: Cohort BExperimental Treatment1 Intervention

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

Group III: Cohort AExperimental Treatment1 Intervention

Men presenting with clinically localized intermediate-risk disease for whom surgery can be safely delayed for neoadjuvant treatment.

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