Status:
COMPLETED
A Study of BLYG8824A in Participants With Locally Advanced or Metastatic Colorectal Cancer
Lead Sponsor:
Genentech, Inc.
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
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
Exclusion
- 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
Key Trial Info
Start Date :
August 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2024
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04468607
Start Date
August 31 2020
End Date
October 16 2024
Last Update
April 25 2025
Active Locations (6)
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1
City of Hope
Duarte, California, United States, 91010
2
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
3
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
4
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain, 31008