Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
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
You may not be if
Pregnant or breastfeeding, or intending to become pregnant during the study or within 4 months after the final dose of BLYG8824A
Significant cardiopulmonary dysfunction
Known clinically significant liver disease
Positive serologic or PCR test results for acute or chronic HBV infection
Acute or chronic HCV infection
HIV seropositivity
Poorly controlled Type 2 diabetes mellitus
Current treatment with medications that are well known to prolong the QT interval
Primary CNS malignancy, untreated CNS metastases, or active CNS metastases
Leptomeningeal disease
Spinal cord compression that has not been definitively treated with surgery and/or radiation
History of autoimmune disease
Prior allogeneic stem cell or solid organ transplantation
Clareo Health | A Study of BLYG8824A in Participants With Locally Advanced or Metastatic Colorectal Cancer
