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BRIEF 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

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

  • Org Study ID: CP-MGD009-01
  • Secondary ID:
  • NCT ID: NCT02628535
  • NCT Alias:
  • Sponsor: MacroGenics - Industry
  • Source: MacroGenics

Brief Summary

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.

Detailed Description

This study is a Phase 1 open-label, dose escalation, cohort expansion, and efficacy follow-up
study of MGD009 administered intravenously (IV) on an every-other-week schedule for up to one
year (14 cycles).

The dose escalation phase is designed to characterize the safety and tolerability of MGD009
and to define the maximum tolerated or maximum administered dose (MTD/MAD). This phase will
enroll patients with mesothelioma, bladder cancer, melanoma, squamous cell carcinoma of the
head and neck (SCCHN), non-small cell lung cancer (NSCLC), clear cell renal cell carcinoma
(ccRCC), ovarian cancer, thyroid cancer, triple-negative breast cancer (TNBC), pancreatic
cancer, colon cancer, soft tissue sarcoma, or prostate cancer.

In the cohort expansion phase, 6 cohorts of 16 patients each will be enrolled to further
evaluate the safety and potential efficacy of MGD009 administered at the MTD/MAD dose in
patients with mesothelioma, bladder cancer, melanoma, SCCHN, NSCLC, or other specific tumors
that express high levels of B7-H3. Pre- and on-study biopsies are required for melanoma
patients in the cohort expansion phase. Two additional cohorts (up to15 patients each) will
evaluate the use of prophylaxis therapies to mitigate toxicity.

The survival follow-up phase consists of the 2-year period after the final dose of study

All tumor evaluations will be carried out by both Response Evaluation Criteria in Solid
Tumors (RECIST) and immune-related response criteria (irRC).

Overal Status Start Date Phase Study Type
Recruiting Start Date: September 2015 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Number of participants with adverse events

Primary Outcome 1 - Time Frame: 28 days after last dose of study drug


  • 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


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

- 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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Stacie Goldberg, M.D.

Role: Study Chair

Affiliation: MacroGenics

Overall Contact

Name: Amy Worth

Phone: 240-660-0757



Facility Status Contact
Los Angeles, California 90095
United States
Active, not recruiting
Stanford University School of Medicine
Palo Alto, California 94304
United States
Recruiting Feriel Buchholz
University of California - San Francisco
San Francisco, California 94143
United States
Recruiting Luat Le
Georgetown University
Washington, District of Columbia 20007
United States
Recruiting Bridget Haley
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Recruiting Miriam McClung
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Recruiting Steve Clark
New York University
New York, New York 10016
United States
Recruiting Peter Warren
Columbia University Medical Center
New York, New York 10032
United States
Active, not recruiting
Carolina BioOncology Institute
Huntersville, North Carolina 28078
United States
Active, not recruiting
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania 19104
United States
Recruiting Michael Galantino
Henry-Joyce Cancer Center
Nashville, Tennessee 37232
United States
Not yet recruiting Jordan Berlin, MD

Mary Crowley Cancer Research Center
Dallas, Texas 75230
United States
Recruiting Jessica Bondurant, BS
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas 78229
United States
Active, not recruiting
Virginia Cancer Specialists
Fairfax, Virginia 22034
United States
Recruiting Kerly Lopez
Chris O'Brien Lifehouse
Camperdown, New South Wales 2050
Active, not recruiting
Saint Vincent's Hospital Sydney
Darlinghurst, New South Wales 2010
Recruiting Amy Prawira, MD
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
Active, not recruiting
Austin Health
Heidelberg, Victoria 3084
Active, not recruiting
Linear Clinical Research
Nedlands, Western Australia 6009
Recruiting Tarek Meniawy, MD
Princess Margaret Cancer Centre
Toronto, Ontario M5G1Z5
Recruiting Aaron Hansen, MD