About the study

This study will evaluate the safety, tolerability, and pharmacokinetics of BLYG8824A and will make a preliminary assessment of the anti-tumor activity of BLYG8824A in patients with locally advanced or metastatic colorectal cancer.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. ECOG performance status of 0 or 1
2. Life expectancy of at least 12 weeks
3. Histologically or cytologically documented invasive CRC: incurable, unresectable, locally advanced or metastatic CRC previously treated with multimodality therapy or mCRC
4. Locally advanced or metastatic CRC that has relapsed or is refractory to established therapies
5. Prior disease progression (or intolerance) following oxaliplatin, irinotecan, fluoropyrimidines, and anti-EGFR monoclonal antibodies
6. An archival tissue specimen or fresh baseline biopsy (when archival is not available) is required for enrollment into the study
7. Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Non-measurable evaluable disease is acceptable for dose-escalation.
8. Adequate hematologic and end organ function
9. Acute, clinically significant treatment-related toxicity from prior therapy resolved to Grade ≤ 1 prior to study entry Expansion Cohort-Specific Inclusion Criteria
10. MSS or MSI-L disease as determined by polymerase chain reaction (PCR) and/or IHC
11. Measurable disease by RECIST v1.1 with at least one measurable target lesion in the expansion cohort
12. Progression must have occurred during or after most recent treatment for locally advanced or metastatic colorectal cancer
13. 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

Exclusion criteria

1. Pregnant or breastfeeding, or intending to become pregnant during the study or within 4 months after the final dose of BLYG8824A
2. Significant cardiopulmonary dysfunction
3. Known clinically significant liver disease
4. Positive serologic or PCR test results for acute or chronic HBV infection
5. Acute or chronic HCV infection
6. HIV seropositivity
7. Poorly controlled Type 2 diabetes mellitus
8. Current treatment with medications that are well known to prolong the QT interval
9. Primary CNS malignancy, untreated CNS metastases, or active CNS metastases
10. Leptomeningeal disease
11. Spinal cord compression that has not been definitively treated with surgery and/or radiation
12. History of autoimmune disease
13. Prior allogeneic stem cell or solid organ transplantation

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.