Phase 1 Study of MGD007 in Relapsed/Refractory Metastatic Colorectal Carcinoma

Exclusion Criteria

• •Known brain metastasis
• •Any prior history of or suspected current autoimmune disorders (with the exception of vitiligo, resolved childhood atopic dermatitis, prior Grave's disease)
• •Prior history of allogeneic bone marrow, stem-cell, or solid organ transplantation
• •Prior treatment with checkpoint inhibitors and other immunotherapy treatments, including anti-LAG-3, anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibodies, if less than 5 half lives before study drug administration
• •Prior history of Grade 3 or greater drug-related diarrhea/colitis during treatment with checkpoint inhibitors or other immunotherapy treatments.
• •Treatment with any local or systemic anti-neoplastic therapy or any other investigational agent in the 4 weeks prior to study drug administration
• •Require, at the time of study entry, treatment with steroids \> 10 mg/day of oral prednisone (or equivalent), except topical use, steroid inhaler, nasal spray or ophthalmic solution
• •History of clinically significant cardiovascular disease, gastrointestinal disorder, or significant pulmonary compromise.
• •Second primary malignancy that has not been in remission for greater than 3 years, with the exception of non-melanoma skin cancer, cervical carcinoma in situ,or squamous intraepithelial lesion on PAP smear, localized prostate cancer (Gleason score \<6), or resected melanoma in situ.