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Checkpoint Inhibitor

Cohort 3 for Prostate Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by MacroGenics
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 every 9 weeks for up to 24 months
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and works well against cancer.

Eligible Conditions
  • Prostate Cancer
  • Non-Small Cell Lung Cancer
  • Oral Squamous Cell Carcinoma
  • Breast Cancer
  • Solid Tumors
  • Melanoma
  • Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 9 weeks for up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 9 weeks for up to 24 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
Number of patients with Adverse Events of vobramitamab duocarmazine as assessed by CTCAE v4.03
Number of patients with dose limiting toxicities (DLT)
Secondary outcome measures
Area under the curve
Best PSA response
Best overall response (BOR) of vobramitamab duocarmazine
+12 more

Trial Design

10Treatment groups
Experimental Treatment
Group I: mCRPC expansionExperimental Treatment1 Intervention
3.0 mg/kg IV every 3 weeks
Group II: TNBC expansionExperimental Treatment1 Intervention
3.0 mg/kg IV every 3 weeks
Group III: SCCHN expansionExperimental Treatment1 Intervention
3.0 mg/kg IV every 3 weeks
Group IV: NSCLC expansionExperimental Treatment1 Intervention
3.0 mg/kg IV every 3 weeks
Group V: Melanoma expansionExperimental Treatment1 Intervention
3.0 mg/kg IV every 3 weeks
Group VI: Cohort 5Experimental Treatment1 Intervention
4.0 mg/kg IV every 3 weeks
Group VII: Cohort 4Experimental Treatment1 Intervention
3.0 mg/kg IV every 3 weeks
Group VIII: Cohort 3Experimental Treatment1 Intervention
2.0 mg/kg IV every 3 weeks
Group IX: Cohort 2Experimental Treatment1 Intervention
1.0 mg/kg IV every 3 weeks
Group X: Cohort 1Experimental Treatment1 Intervention
0.5 mg/kg IV every 3 weeks

Find a Location

Who is running the clinical trial?

MacroGenicsLead Sponsor
48 Previous Clinical Trials
5,233 Total Patients Enrolled
4 Trials studying Prostate Cancer
498 Patients Enrolled for Prostate Cancer
Ashley Ward, M.D.Study DirectorMacroGenics
2 Previous Clinical Trials
472 Total Patients Enrolled
Chet Bohac, PharmD MD MScStudy DirectorMacroGenics
1 Previous Clinical Trials
145 Total Patients Enrolled

Frequently Asked Questions

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

Is MGC018 a new or novel medication?

"There are currently 26 independent trials studying MGC018 with 3 of them being Phase 3 clinical trials. Most studies are based in A CORU�A and Virginia; however, there are 810 total sites running these investigations."

Answered by AI

What is different or unique about this particular clinical trial?

"MGC018 has been under investigation since 2016. The first clinical trial, sponsored by Incyte Corporation concluded that same year. After the successful Phase 1 drug approval in 2016, there are now 26 active MGC018 studies being conducted in 117 cities and 43 countries."

Answered by AI

Are there anycurrent openings for participants in this trial?

"According to the listing on clinicaltrials.gov, this trial is no longer actively recruiting patients. The study was first posted on 11/21/2018 and has not been updated since 11/2/2022. Even though this particular trial is not taking any more participants, there are 2180 other trials currently enrolling patients."

Answered by AI

What goals does this trial hope to accomplish?

"The primary outcome of this study, which will be assessed over the course of 24 months, is the number of patients experiencing adverse events while taking MGC018. This will be measured using CTCAE v4.03. Secondary outcomes include the area under the curve for plasma concentration versus time curves of vobramitamab duocarmazine and vobramitamab duocarmazine+retifanlimab, overall survival rate of MGC018 efficacy as best overall response rate using RECIST v1.1, and objective response rate of vobramitamab duocarmazine defined as the number"

Answered by AI

How many individuals are being treated as part of this research project?

"This particular study is not recruiting patients at the moment, having last updated their posting on November 2nd, 2022. There are, however, 26 other trials related to MGC018 and 2154 studies concerning oral squamous cell carcinoma that are currently looking for participants."

Answered by AI

In how many different medical institutions is this research being conducted?

"At the moment, there are 8 different hospitals conducting this clinical trial. If you live near Fairfax, Washington or Las Vegas, please consider enrolling as these will minimize travel time and effort."

Answered by AI
~22 spots leftby Apr 2025