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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 day 1 of every 21-day cycle, throughout the study, average of 1 year.
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to test the safety, effectiveness, and potential anti-cancer effects of MGC026 in individuals with advanced solid tumors. Participants will receive MGC026 through intravenous infusion and may undergo
Who is the study for?
Adults over 18 with advanced solid tumors that can't be removed by surgery, including various cancers like lung, prostate, bladder, and more. They must measure their disease progress using RECIST v1.1 criteria and agree to use effective birth control methods. Pregnant or breastfeeding individuals cannot participate.
What is being tested?
The trial is testing MGC026's safety and effectiveness against different advanced solid tumors. Participants will receive up to 35 IV infusions of MGC026 in increasing doses until side effects become severe or the cancer worsens.
What are the potential side effects?
While specific side effects are not listed here, participants will be closely monitored for any adverse reactions to MGC026 during treatment and through blood tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 of every 21-day cycle, throughout the study, average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 of every 21-day cycle, throughout the study, average of 1 year.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
DoR in mCRPC
Duration of response (DoR) in advanced solid tumors
Mean (SD) of MGC026 area under the time concentration curve (AUC)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
10Treatment groups
Experimental Treatment
Group I: Expansion cohort 4Experimental Treatment1 Intervention
Group II: Expansion cohort 3Experimental Treatment1 Intervention
Group III: Expansion cohort 2Experimental Treatment1 Intervention
Group IV: Expansion cohort 1Experimental Treatment1 Intervention
Group V: Cohort 6Experimental Treatment1 Intervention
Group VI: Cohort 5Experimental Treatment1 Intervention
Group VII: Cohort 4Experimental Treatment1 Intervention
Group VIII: Cohort 3Experimental Treatment1 Intervention
Group IX: Cohort 2Experimental Treatment1 Intervention
Group X: Cohort 1Experimental Treatment1 Intervention
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Who is running the clinical trial?
MacroGenicsLead Sponsor
48 Previous Clinical Trials
4,902 Total Patients Enrolled
Denise Casey, MDStudy DirectorMacroGenics
1 Previous Clinical Trials
162 Total Patients Enrolled
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