A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms

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

• Advanced Solid Tumors
• Hematologic Neoplasms
• Ovarian Cancer
• HER2-positive Advanced Solid Tumors
• Non Small Cell Lung Cancer
• Small-cell Lung Cancer
• Squamous Cell Carcinoma of Head and Neck
• Cholangiocarcinoma
• Cervical Cancer
• TNBC - Triple-Negative Breast Cancer

Interventions

BIOLOGICAL

tebotelimab 1 mg

1 mg IV every other week

BIOLOGICAL

tebotelimab 3 mg

3 mg IV every other week

BIOLOGICAL

tebotelimab 10 mg

10 mg IV every other week

BIOLOGICAL

tebotelimab 30 mg

30 mg IV every other week

BIOLOGICAL

tebotelimab 120 mg

120 mg IV every other week

BIOLOGICAL

tebotelimab 300 mg

300 mg IV every other wee

BIOLOGICAL

tebotelimab 400 mg

400 mg IV every other wee

BIOLOGICAL

tebotelimab 600 mg

600 mg IV every other week

BIOLOGICAL

tebotelimab 800 mg

800 mg IV every other week

BIOLOGICAL

tebotelimab 1200 mg

1200 mg IV every other week

BIOLOGICAL

margetuximab

15 mg/kg IV every 3 weeks

Sponsors & Collaborators

• MacroGenics

  lead INDUSTRY

Principal Investigators

• Ashley Ward, MD · MacroGenics

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-18

Primary Completion

2023-02-08

Completion

2023-02-08

FDA Drug

Yes

Countries

• United States
• Australia
• Bulgaria
• Hong Kong
• Poland
• Spain
• Thailand
• Ukraine

Study Locations