Clinical Trial - NCT02628535

Safety Study of MGD009 in B7-H3-expressing Tumors


Sponsor: MacroGenics


Information provided by (Responsible party): Sponsor Identifier: NCT02628535

Protocol Info

Short Description: Phase 1 MGD009 in B7-H3-Expressing Neoplasms
Long Description: A Phase 1, First-in-Human, Open Label, Dose Escalation Study of MGD009, A Humanized B7-H3 x CD3 Dual-Affinity Re-Targeting (DART®) Protein in Patients with Unresectable or Metastatic B7-H3-Expressing Neoplasms and Neoplasms whose Vasculature Expresses B7-H3
MGH Status: Closed
Sponsor: MacroGenics, Inc.
Disease Program: Phase I

Next Steps

If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.


The purpose of this study is to evaluate the safety of MGD009 when given to patients with B7-H3-expressing tumors. The study will also evaluate what is the highest dose of MGD009 that can be given safely. Assessments will be done to see how the drug acts in the body (pharmacokinetics (PK), pharmacodynamics (PD) and to evaluate potential anti-tumor activity of MGD009.
Condition Title Intervention Phase
Mesothelioma Bladder Cancer Melanoma Squamous Cell Carcinoma of the Head and Neck Non Small Cell Lung Cancer Clear Cell Renal Cell Carcinoma Ovarian Cancer Thyroid Cancer Breast Cancer Pancreatic Cancer Prostate Cancer Colon Cancer Soft Tissue Sarcoma MGD009 Phase 1
Study Type Interventional
Official Title Phase 1, First-in-Human, Open Label, Dose Escalation Study of MGD009, A Humanized B7-H3 x CD3 Dual-Affinity Re-Targeting (DART) Protein in Patients With Unresectable or Metastatic B7-H3-Expressing Neoplasms

Primary Outcome Measures

Number of participants with adverse events [Time Frame: 28 days after last dose of study drug] [Designated as safety issue: ]

Secondary Outcome Measures

Peak plasma concentration [Time Frame: 8 days] [Designated as safety issue: ]

Number of participants that develop anti-drug antibodies [Time Frame: first dose through 28 days after last dose of study drug] [Designated as safety issue: ]

Change in tumor volume [Time Frame: Weeks 6, 15, 24, 33, 42, 51, 60, 69, 78, 87, 96, 105] [Designated as safety issue: ]

Estimated Enrollment: 67
Study Start Date: September 2015
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2019
Arms Assigned Interventions


Orlotamab; Humanized B7-H3 x CD3 Dual-Affinity Re-Targeting (DART®) Protein
B7-H3 x CD3 DART protein


Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

Inclusion Criteria:

  • Histologically and/or cytologically proven unresectable locally advanced or metastatic tumors that express B7-H3 on the membrane or vasculature. The requirement for previous systemic therapy may be waived if a person was intolerant of standard front-line therapy
  • Dose escalation phase prior systemic treatment requirements:
  • pleural mesothelioma, pancreatic cancer: 1-3 prior treatments
  • urothelial, SCHNN, prostate, soft tissue sarcoma, prostate cancer, TNBC, ccRCC, NSCLC: 1-5 prior treatments
  • ovarian cancer: 2-4 prior treatments
  • colon cancer: 2-4 prior treatments
  • cutaneous melanoma: at least 1 prior treatment (including immunotherapy).
  • Patients with prior immune checkpoint inhibitors must have related toxicities reduced to Grade 0, 1, or baseline
  • Measurable disease per RECIST 1.1 criteria
  • Easter Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Acceptable laboratory parameters and adequate organ reserve.

Exclusion Criteria:

  • Patients with central nervous system (CNS) involvement must have been treated, be asymptomatic, do not exhibit progression of CNS metastases on MRI or CT within 28 days, and do not have concurrent leptomeningeal disease or cord compression.
  • Clinically significant pulmonary compromise within 28 days of first dose, including pneumonia, pneumonitis, requirement for supplemental oxygen). use to maintain adequate oxygenation, or pleural effusion sufficient to warrant pleurocentesis or any history of ≥ Grade 3 drug induced or radiation pneumonitis.
  • History of autoimmune disease with certain exceptions such as vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic therapy within the past 2 years, patients with history of Hashimoto's or Grave's disease that are now euthyroid clinically and by lab testing
  • History of clinically-significant cardiovascular disease, or cardiac arrhythmias, including atrial fibrillation at screening or day of treatment
  • History of clinically-significant gastrointestinal (GI) disease; GI perforation within 1 year; GI bleeding or acute pancreatitis within 3 months; or diverticulitis within 4 weeks of first study drug administration
  • Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days of first study drug administration
  • Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction (PCR)
  • Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome
  • History of allogeneic bone marrow, stem cell, or solid organ transplant
  • Treatment with systemic cancer therapy or investigational therapy within 3 weeks of first study drug administration; radiation within 2 weeks; corticosteroids (greater than or equal to 10 mg prednisone or equivalent per day) or other immune suppressive drugs within 2 weeks of first study drug administration
  • Trauma or major surgery within 4 weeks of first study drug administration
  • Known hypersensitivity to recombinant proteins, polysorbate 80, or any excipient contained in the drug or vehicle formulation for MGD009

Contacts and Locations

Please refer to this study by its identifier: NCT02628535


  • United States, California
    • UCLA Los Angeles, California, United States, 90095
    • Stanford University School of Medicine Palo Alto, California, United States, 94304
    • University of California - San Francisco San Francisco, California, United States, 94143
  • United States, District of Columbia
    • Georgetown University Washington, District of Columbia, United States, 20007
  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
    • Dana Farber Cancer Institute Boston, Massachusetts, United States, 02215
  • United States, New York
    • New York University New York, New York, United States, 10016
    • Columbia University Medical Center New York, New York, United States, 10032
  • United States, North Carolina
    • Carolina BioOncology Institute Huntersville, North Carolina, United States, 28078
  • United States, Pennsylvania
    • Penn Presbyterian Medical Center Philadelphia, Pennsylvania, United States, 19104
  • United States, Tennessee
    • Henry-Joyce Cancer Center Nashville, Tennessee, United States, 37232
  • United States, Texas
    • Mary Crowley Cancer Research Center Dallas, Texas, United States, 75230
    • South Texas Accelerated Research Therapeutics, LLC San Antonio, Texas, United States, 78229
  • United States, Virginia
    • Virginia Cancer Specialists Fairfax, Virginia, United States, 22034
  • Australia, New South Wales
    • Chris O'Brien Lifehouse Camperdown, New South Wales, Australia, 2050
    • Saint Vincent's Hospital Sydney Darlinghurst, New South Wales, Australia, 2010
  • Australia, Queensland
    • Princess Alexandra Hospital Woolloongabba, Queensland, Australia, 4102
  • Australia, Victoria
    • Austin Health Heidelberg, Victoria, Australia, 3084
  • Australia, Western Australia
    • Linear Clinical Research Nedlands, Western Australia, Australia, 6009
  • Canada, Ontario
    • Princess Margaret Cancer Centre Toronto, Ontario, Canada, M5G1Z5

Sponsors and Collaborators


More Information

No publications provided

Responsible Party: Sponsor Identifier: NCT02628535
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by MacroGenics:

B7-H3-expressing neoplasms

Additional relevant MeSH terms:



Carcinoma, Renal Cell


Squamous Cell Carcinoma of Head and Neck

Next Steps

If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation. processed this data on September 03, 2020