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Enoblituzumab for Prostate Cancer

Phase 2
Waitlist Available
Led By Emmanuel Antonarakis, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed adenocarcinoma of the prostate (clinical stage T1c-T3b, N0, M0) without involvement of lymph nodes, bone, or visceral organs
Adequate bone marrow, hepatic, and renal function:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post-prostatectomy
Awards & highlights

Study Summary

This trial will test a new drug, Enoblituzumab, to see if it is safe and effective against prostate cancer. Patients will receive the drug for 6 weeks before surgery.

Who is the study for?
Men over 18 with intermediate/high-risk localized prostate cancer (stage T1c-T3b, N0, M0) can join. They must have a scheduled radical prostatectomy at Johns Hopkins Hospital, good physical health and organ function, and agree to use barrier contraception from the first dose until surgery. Excluded are those who've had prior treatments for prostate cancer or other cancers in the last 3 years (except certain skin/bladder cancers), autoimmune diseases needing immunosuppression, major illnesses, or known HIV/hepatitis B/C.Check my eligibility
What is being tested?
The trial is testing Enoblituzumab's safety and effectiveness when given before surgical removal of the prostate. Participants will receive six weekly doses starting about seven weeks before their surgery to see if it helps reduce tumor size and affects immune response.See study design
What are the potential side effects?
Possible side effects of Enoblituzumab may include reactions at the injection site, flu-like symptoms such as fever or chills, fatigue, nausea, changes in blood pressure or heart rate. More serious but less common could be allergic reactions or effects on immune system causing it to attack normal cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My prostate cancer is confirmed and has not spread to lymph nodes, bones, or other organs.
Select...
My liver, kidneys, and bone marrow are working well.
Select...
I am fully active or able to carry out light work.
Select...
I am scheduled for a major prostate surgery at Johns Hopkins Hospital.
Select...
My liver function tests have been checked before joining the study.
Select...
I agree to use barrier contraception from the start of treatment until my prostate surgery.
Select...
My initial prostate biopsy shows at least 2 positive cores and a Gleason score of 7 or higher.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post-prostatectomy
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post-prostatectomy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of Neoadjuvant Enoblituzumab as Assessed by PSA0 Response Rate
Number of Participants With Treatment-related Adverse Events
Secondary outcome measures
CD4+ T Cell Infiltration
CD8-Positive T-Lymphocytes
Enoblituzumab (MGA271) Drug Distribution Evaluated by Detection of MGA271 in Tumor Tissue
+10 more
Other outcome measures
Androgen Receptor (AR) Quantification
B7-H3 Expression
FC Receptor Genotyping
+7 more

Side effects data

From 2022 Phase 1 trial • 3 Patients • NCT04630769
100%
Investigations - Other, specify
100%
Abdominal pain
100%
Infections and infestations - Other,
100%
Nausea
100%
Skin infection
100%
Blood and lymphatic system disorders - Other, specify
100%
Lymphocyte count decreased
100%
White blood cell decreased
100%
Thromboembolic event
100%
Anemia
100%
Blood lactate dehydrogenase increased
100%
Abdominal distension
100%
Small intestinal obstruction
100%
Anorexia
100%
Diarrhea
100%
Vomiting
100%
Sore throat
100%
Dyspepsia
100%
Constipation
100%
General disorders and administration site conditions - Other, specify
100%
Hepatobiliary disorders - Other, specify
100%
Hypocalcemia
100%
Neutrophil count decreased
100%
Hypoalbuminemia
100%
Renal and urinary disorders - Other, specify
100%
Proteinuria
100%
Edema limbs
100%
Fatigue
100%
Urinary tract infection
100%
Hypomagnesemia
100%
Hyponatremia
100%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Monotherapy: IP FT516 at 9 x 10^7 Cells/Dose on Day 1, 8, and 15
Monotherapy: IP FT516 at 9 x 10^8 Cells/Dose on Day 1, 8, and 15
Monotherapy: IP FT516 at 3 x 10^8 Cells/Dose on Day 1, 8, and 15

Trial Design

1Treatment groups
Experimental Treatment
Group I: EnoblituzumabExperimental Treatment1 Intervention
Men with localized intermediate and high-risk prostate cancer will be given neoadjuvant Enoblituzumab 15mg/kg IV weekly for 6 weeks followed by radical prostatectomy on day 50, with follow-up visits 30 days and 90 days post-prostatectomy. PSA values will be tracked for 3 years post-prostatectomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enoblituzumab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,867 Total Patients Enrolled
56 Trials studying Prostate Cancer
3,315 Patients Enrolled for Prostate Cancer
MacroGenicsIndustry Sponsor
48 Previous Clinical Trials
5,343 Total Patients Enrolled
3 Trials studying Prostate Cancer
465 Patients Enrolled for Prostate Cancer
Emmanuel Antonarakis, MDPrincipal InvestigatorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
3 Previous Clinical Trials
70 Total Patients Enrolled
2 Trials studying Prostate Cancer
58 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.

What is the cap on participants in this research trial?

"This research project has concluded its recruitment phase. It was initially advertised on February 14th 2017 and last modified on December 7th 2022. Nevertheless, there are presently 1326 clinical trials searching for prostate cancer patients and one seeking volunteers to test Enoblituzumab."

Answered by AI

Have there been any other investigations into the effects of Enoblituzumab?

"Currently, there is one active research project investigating enoblituzumab and it has yet to reach Phase 3. While most of the trials for this drug are being performed in Baltimore, Maryland, a single other medical centre also offers testing with this medication."

Answered by AI

What are the main goals of this clinical experimentation?

"During this two year trial, the primary focus is to assess neoadjuvant enoblituzumab's efficacy through PSA0 response rate. Secondary objectives include evaluating participants' pathological complete responses (pCR) and Gleason Grade Group Change as well as quantifying markers of apoptosis in prostate tumor specimens of treated patients via TUNEL staining."

Answered by AI

Has Enoblituzumab earned endorsement from the FDA?

"This Phase 2 trial has generated some evidence indicating Enoblituzumab's safety, thus garnering a score of 2. Nonetheless, there is still no empirical proof that this medication can be effective at treating its respective conditions."

Answered by AI

Are there any current openings for participation in this experiment?

"As reported on clinicaltrials.gov, this specific trial has concluded its recruitment phase and is no longer looking for individuals to participate. This study was first announced in February 2017 with the last modification being made in December 2022; however, 1327 other trials are still actively seeking participants at this time."

Answered by AI

Is this research a pioneering venture?

"Currently, there is an active clinical trial for enoblituzumab running in 1 city and 1 nation. This drug was initially tested back in 2017 by MacroGenics with 33 participants concluding its Phase 2 trials. Since then, 5 studies have been concluded."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Neoadjuvant Enoblituzumab (MGA271) in Men With Localized Intermediate and High-Risk Prostate Cancer
2017. "Neoadjuvant Enoblituzumab (MGA271) in Men With Localized Intermediate and High-Risk Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02923180.
~4 spots leftby Apr 2025
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