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Checkpoint Inhibitor

MGC018 With or Without MGA012 in Advanced Solid Tumors

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
No Placebo-Only Group

Summary

This trial is testing a new drug called vobramitamab duocarmazine in patients with advanced solid tumors. It aims to see if the drug is safe and effective in treating these cancers by targeting and killing cancer cells. The study includes patients with several specific types of difficult-to-treat cancers.

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of patients with Adverse Events of vobramitamab duocarmazine as assessed by CTCAE v4.03
Number of patients with dose limiting toxicities (DLT)
Secondary study objectives
Area under the curve
Best PSA response
Best overall response (BOR) of vobramitamab duocarmazine
+12 more

Awards & 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: 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
50 Previous Clinical Trials
5,213 Total Patients Enrolled
Ashley Ward, M.D.Study DirectorMacroGenics
2 Previous Clinical Trials
322 Total Patients Enrolled
Chet Bohac, PharmD MD MScStudy DirectorMacroGenics
1 Previous Clinical Trials
145 Total Patients Enrolled
~20 spots leftby Dec 2025
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