Clinical Trials Directory

Trials / Completed

CompletedNCT03219268

A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms

A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of MGD013, A Bispecific DART® Protein Binding PD-1 and LAG-3 in Patients With Unresectable or Metastatic Neoplasms

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
277 (actual)
Sponsor
MacroGenics · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The primary goal of this Phase 1 study is to characterize the safety and tolerability of tebotelimab and establish the maximum tolerated dose (MTD) of tebotelimab in advanced solid tumors, and tebotelimab in combination with margetuximab in HER2+ advanced solid tumors. Pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD), and the anti-tumor activity of tebotelimab will also be assessed.

Conditions

Interventions

TypeNameDescription
BIOLOGICALtebotelimab 1 mg1 mg IV every other week
BIOLOGICALtebotelimab 3 mg3 mg IV every other week
BIOLOGICALtebotelimab 10 mg10 mg IV every other week
BIOLOGICALtebotelimab 30 mg30 mg IV every other week
BIOLOGICALtebotelimab 120 mg120 mg IV every other week
BIOLOGICALtebotelimab 300 mg300 mg IV every other wee
BIOLOGICALtebotelimab 400 mg400 mg IV every other wee
BIOLOGICALtebotelimab 600 mg600 mg IV every other week
BIOLOGICALtebotelimab 800 mg800 mg IV every other week
BIOLOGICALtebotelimab 1200 mg1200 mg IV every other week
BIOLOGICALmargetuximab15 mg/kg IV every 3 weeks

Timeline

Start date
2017-08-18
Primary completion
2023-02-08
Completion
2023-02-08
First posted
2017-07-17
Last updated
2023-12-21

Locations

40 sites across 8 countries: United States, Australia, Bulgaria, Hong Kong, Poland, Spain, Thailand, Ukraine

Regulatory

Source: ClinicalTrials.gov record NCT03219268. Inclusion in this directory is not an endorsement.