A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of MGC018 (Anti–B7-H3 Antibody Drug Conjugate) Alone and in Combination with MGA012 (Anti–PD-1 Antibody) in Patients with Advanced Solid Tumors (MGC018-01)

The purpose of this study is to test the safety and effectiveness of a drug called MGC018 alone or in combination with another drug called MGA012 (also known as INCMGA00012).

Both MGC018 and MGA012 are monoclonal antibodies. When the body’s immune system detects something harmful, it produces antibodies. Antibodies are proteins that fight infection. Monoclonal antibodies are a specific type of antibody made in a laboratory. Antibodies work by attaching to sick or damaged cells and telling immune cells in the body to attack them.

MGC018 is a monoclonal antibody with an active chemotherapy drug attached to it. MGC018 is made to attach to a protein called B7-H3 which is expressed at high levels on certain cancer cells. By attaching to cancer cells, MGC018 delivers the chemotherapy drug to the cancer cell. Although MGC018 alone has been studied in animals, this study is the first time MGC018 will be given to humans to be tested as a possible treatment for cancer, and MGC018 has not been tested in combination with MGA012.

MGA012 is a monoclonal antibody that attaches to a protein on the surface of cells known as PD-1. PD-1 normally exists in your body and keeps your immune system from attacking your own body. Some cancer cells take control of the PD-1 pathway to hide from the immune system. MGA012 attaches to the PD-1 protein, allowing the immune system to attack the cancer cells. There are other PD-1 targeting drugs that are approved by the FDA to treat several types of cancers. MGA012 has been given separately to subjects in other clinical trials. This is the first clinical trial where subjects will receive both MGA012 and MGC018 in combination.

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031

A department of Inova Fairfax Hospital

• Over the age of 18 years
• Archival tissue or formalin-fixed paraffin-embedded (FFPE) tissue must be available for B7-H3 and PD-L1 (testing on all patients enrolled). Tumor specimens for determination of B7-H3 and PD-L1 expression via IHC staining will be collected on all patients during both Dose Escalation and Cohort Expansion. Determination of B7-H3 and PD-L1 IHC testing results will not be required prior to protocol enrollment
• Patients may undergo a fresh tumor biopsy to obtain a specimen for testing if a suitable sample cannot be identified
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Measurable disease as per RECIST v1.1 criteria and documented by computed tomography (CT) and/or magnetic resonance imaging (MRI)
• Additional eligibility in protocol

• Active Central Nervous System metastasis
• Known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment (within the past 2 years), and patients with a history of Grave’s disease that are now euthyroid clinically and by laboratory testing
• Additional ineligibility in protocol

For more information, go to: https://clinicaltrials.gov/ct2/show/NCT03729596