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Monoclonal Antibodies

huJ591 for Prostate Cancer

Phase 1

Waitlist Available

Led By Scott Tagawa, MD

Research Sponsored by Weill Medical College of Cornell University

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 response will be measured by performing ct scans every 3 months from baseline until the date of first documented progression, or death from any cause, whichever came first assessed up to 100 months

Awards & highlights

Study Summary

This trial is for men with advanced prostate cancer. The purpose is to treat patients with an experimental antibody called J591 that attaches itself to a special protein on cancer cells called PSMA to try to eliminate these cancer cells from the circulation.

Eligible Conditions

Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ response will be measured by performing ct scans every 3 months from baseline until the date of first documented progression, or death from any cause, whichever came first assessed up to 100 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~response will be measured by performing ct scans every 3 months from baseline until the date of first documented progression, or death from any cause, whichever came first assessed up to 100 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and response will be measured by performing ct scans every 3 months from baseline until the date of first documented progression, or death from any cause, whichever came first assessed up to 100 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Changes in frequency of achieving a decrease in Circulating tumor count (CTC)

Secondary outcome measures

Change in disease response through the optional (but recommended) prostate specific membrane antigen (PSMA) PET/CT imaging

Change in duration of Circulating tumor count (CTC) response

Changes in prostate specific antigen (PSA) measurable disease response

Trial Design

1Treatment groups

Experimental Treatment

Group I: HuJ591 AdministrationExperimental Treatment1 Intervention

6 subjects will be treated at 300 mg dose. The decision about treating subjects at the lower dose will depend upon their response. If ≥4 of 6 subjects respond at the 300 mg level, then 6 more subjects will be recruited at the 200 mg level. If ≥4 of 6 subjects respond at the 200 mg level than 6 more subjects will be recruited at the next dose level of 100 mg. If ≥ 4/6 subjects respond at this level, then 6 subjects will be recruited at the last dose level of 50 mg. At any level, if the first four consecutive subjects respond, the next two subjects will be enrolled in the same dose-level cohort and further subjects will be recruited at the next dose level. Response at every dose level is defined by conversion from an unfavorable CTC count at baseline to a favorable CTC count.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

huJ591

2016

Completed Phase 1

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,055 Previous Clinical Trials

1,316,285 Total Patients Enrolled

48 Trials studying Prostate Cancer

35,629 Patients Enrolled for Prostate Cancer

Scott Tagawa, MDPrincipal InvestigatorWeill Medical College of Cornell University

7 Previous Clinical Trials

239 Total Patients Enrolled

6 Trials studying Prostate Cancer

219 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

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

Is recruitment of participants still ongoing for this clinical trial?

"According to the information posted on clinicaltrials.gov, this trial is not currently recruiting participants as it was last edited on April 20th of 2022. Despite this fact, there are 1,345 other medical studies that require enrolment right now."

Answered by AI