Safety Study of MGD009 in B7-H3-expressing Tumors

Not Recruiting

Trial ID: NCT02628535


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.

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

Stanford Investigator(s)

Kristen N Ganjoo
Kristen N Ganjoo

Professor of Medicine (Oncology)

Sunil Arani Reddy
Sunil Arani Reddy

Clinical Associate Professor, Medicine - Oncology


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


biological: MGD009

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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