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A Study of BLYG8824A in Participants With Locally Advanced or Metastatic Colorectal Cancer
- Cancer
- Colorectal Cancer (CRC)
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:
Completed
This study runs in
City
- Nashville
Trial Identifier:
NCT04468607 GO41751
The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
Study 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 metastatic colorectal cancer.
Genentech, Inc.
Sponsor
Phase 1
Phase
NCT04468607, GO41751
Trial Identifier
BLYG8824A
Treatments
Colorectal Cancer
Condition
Official Title
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
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- 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 Criteria
- 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
For the latest version of this information please go to www.forpatients.roche.com