← Back to Search

Monoclonal Antibodies

REGN5678 Before Surgery for High-Risk Prostate Cancer

Phase 1 & 2

Recruiting

Led By Sumit Subudhi, MD, PHD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Men ≥18 years of age

Serum creatinine ≤1.5 x ULN or estimated glomerular filtration rate >50 mL/min/1.73 m2.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

Study Summary

This trial will study the safety and effects of a drug on patients with high-risk prostate cancer.

Who is the study for?

Men over 18 with high-risk, localized prostate cancer that hasn't spread and is operable. They must have a specific Gleason score from recent biopsies, good organ function, no prior prostate cancer treatments, and an ECOG performance status of 0 or 1. Participants need to agree to use condoms during the study and for three months after.Check my eligibility

What is being tested?

The trial tests REGN5678 (an experimental drug) in combination with Piflufolastat F18 before patients undergo surgery for prostate cancer. The goal is to assess the safety and effects of REGN5678 on men preparing for radical prostatectomy.See study design

What are the potential side effects?

Potential side effects may include immune system reactions, inflammation in various organs due to the drug's mechanism of action targeting PSMA x CD28 pathways, as well as typical risks associated with new anticancer therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a man aged 18 or older.

Select...

My kidney function is within the normal range.

Select...

I am fully active or can carry out light work.

Select...

My prostate cancer is in a stage where surgery to remove it is possible.

Select...

I have not had any treatment for prostate cancer, except possibly TURP.

Select...

My prostate cancer is aggressive, based on a recent biopsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Design

1Treatment groups

Experimental Treatment

Group I: REGN5678 (anti-PSMAxCD28)Experimental Treatment2 Interventions

Participants will receive REGN5678 by vein over about 2 hours the first time you receive it. Participants will be admitted to the hospital, where participants will be monitored for side effects. Other doses may be given over 30-90 minutes depending on how you handle the dose. Participants will receive REGN5678 weekly for 6 weeks.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,975 Previous Clinical Trials

1,789,477 Total Patients Enrolled

95 Trials studying Prostate Cancer

29,698 Patients Enrolled for Prostate Cancer

Sumit Subudhi, MD, PHDPrincipal InvestigatorM.D. Anderson Cancer Center

Sumit K Subudhi, MD, PHDPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining opportunities for individuals to partake in this research endeavor?

"According to the clinicaltrials.gov website, this research project is not currently taking part in participant recruitment - it was initially posted on March 1st 2024 and last updated October 10th 2023. However, there are over 1300 other experiments actively recruiting volunteers at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Pilot Presurgical Trial of REGN5678 (Anti-PSMA x CD28) in Patients With High-risk, Localized Prostate Cancer Followed by Radical Prostatectomy

2023. "A Pilot Presurgical Trial of REGN5678 (Anti-PSMA x CD28) in Patients With High-risk, Localized Prostate Cancer Followed by Radical Prostatectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06085664.

All > Mens Health