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Monoclonal Antibodies

A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms

Phase 1
Waitlist Available
Led By Bradley Sumrow, MD
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 throughout the study, up to 4 years.
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer drug to see how safe and effective it is.

Eligible Conditions
  • Hematopoietic Stem Cell Transplantation for Pediatric Hematological Malignancies
  • Squamous Cell Carcinoma
  • Cholangiocarcinoma
  • Lung Cancer
  • Ovarian Cancer
  • Bile Duct Cancer
  • Blood Cancers
  • Solid Tumors
  • Non-Small Cell Lung Cancer
  • Cervical Cancer
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study, up to 4 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study, up to 4 years. 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 participants with Treatment-Emergent Adverse Events (TEAE) as assessed by CTCAE v4.03 (tebotelimab monotherapy)
Number of participants with Treatment-Emergent Adverse Events as assessed by CTCAE v4.03 (tebotelimab plus margetuximab)
Secondary study objectives
Apparent volume of distribution at steady state (Vss) of tebotelimab
Area Under the Plasma Concentration versus Time Curve (AUC) of tebotelimab
Maximum Plasma Concentration (Cmax) of tebotelimab and tebotelimab plus margetuximab
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

12Treatment groups
Experimental Treatment
Group I: Tebotelimab: 800 mgExperimental Treatment1 Intervention
Group II: Tebotelimab: 600 mgExperimental Treatment1 Intervention
Group III: Tebotelimab: 400 mgExperimental Treatment1 Intervention
Group IV: Tebotelimab: 30 mgExperimental Treatment1 Intervention
Group V: Tebotelimab: 1200 mgExperimental Treatment1 Intervention
Group VI: Tebotelimab: 120 mgExperimental Treatment1 Intervention
Group VII: Tebotelimab: 10 mgExperimental Treatment1 Intervention
Group VIII: Tebotelimab: 1 mgExperimental Treatment1 Intervention
Group IX: Tebotelimab 3 mgExperimental Treatment1 Intervention
Group X: Monotherapy Cohort ExpansionExperimental Treatment1 Intervention
Monotherapy expansion at 600 mg
Group XI: Combination cohort 1Experimental Treatment2 Interventions
Tebotelimab and margetuximab
Group XII: Combination Cohort 2Experimental Treatment2 Interventions
Tebotelimab and margetuximab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tebotelimab 10 mg
2017
Completed Phase 1
~280
tebotelimab 3 mg
2017
Completed Phase 1
~280
tebotelimab 300 mg
2017
Completed Phase 1
~280
tebotelimab 30 mg
2017
Completed Phase 1
~280
tebotelimab 1 mg
2017
Completed Phase 1
~280
tebotelimab 120 mg
2017
Completed Phase 1
~280
tebotelimab 400 mg
2017
Completed Phase 1
~280
tebotelimab 600 mg
2017
Completed Phase 1
~280
tebotelimab 800 mg
2017
Completed Phase 1
~280
tebotelimab 1200 mg
2017
Completed Phase 1
~280
margetuximab
2017
Completed Phase 1
~350

Find a Location

Who is running the clinical trial?

MacroGenicsLead Sponsor
50 Previous Clinical Trials
5,079 Total Patients Enrolled
Bradley Sumrow, MDPrincipal InvestigatorMacroGenics
1 Previous Clinical Trials
162 Total Patients Enrolled
Ashley Ward, MDStudy DirectorMacroGenics
2 Previous Clinical Trials
24 Total Patients Enrolled
~33 spots leftby Dec 2025
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