This phase I study is trying to understand how safe, tolerable and effective a new anti-cancer drug (BLYG8824A) is in people with colorectal cancer.A Phase I, Open-Label, Dose-Escalation Study Of The Safety And Pharmacokinetics Of BLYG8824A Administered Intravenously In Patients With Locally Advanced Or Metastatic Colorectal Cancer

Inclusion

• ECOG performance status of 0 or 1
• Life expectancy of at least 12 weeks
• Histologically or cytologically documented invasive CRC: incurable, unresectable, locally advanced or metastatic CRC previously treated with multimodality therapy or mCRC
• Locally advanced or metastatic CRC that has relapsed or is refractory to established therapies
• Prior disease progression (or intolerance) following oxaliplatin, irinotecan, fluoropyrimidines, and anti-EGFR monoclonal antibodies
• An archival tissue specimen or fresh baseline biopsy (when archival is not available) is required for enrollment into the study
• Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Non-measurable evaluable disease is acceptable for dose-escalation.
• Adequate hematologic and end organ function
• Acute, clinically significant treatment-related toxicity from prior therapy resolved to Grade ≤ 1 prior to study entry

Expansion Cohort-Specific Inclusion Criteria

• MSS or MSI-L disease as determined by polymerase chain reaction (PCR) and/or IHC
• Measurable disease by RECIST v1.1 with at least one measurable target lesion in the expansion cohort
• Progression must have occurred during or after most recent treatment for locally advanced or metastatic colorectal cancer
• For patients enrolled in either a dedicated biopsy cohort or other expansion cohorts where biopsy is clinically feasible, willingness to consent to mandatory fresh pretreatment and on-treatment biopsies of safely accessible tumor lesions