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

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      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

       

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