Clinical Trials /

A Study of BLYG8824A in Participants With Locally Advanced or Metastatic Colorectal Cancer

NCT04468607

Description:

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.

Related Conditions:
  • Colorectal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of BLYG8824A in Participants With Locally Advanced or Metastatic Colorectal Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: GO41751
  • NCT ID: NCT04468607

Conditions

  • Colorectal Cancer

Interventions

DrugSynonymsArms
BLYG8824ADose-Escalation Stage

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Dose-Escalation StageExperimentalParticipants will be assigned sequentially to escalating doses of BLYG8824A, up to the maximum tolerated dose (MTD).
  • BLYG8824A
Dose-Expansion StageExperimentalOnce dose escalation is completed and the MTD (or MAD) has been identified, a recommended expansion dose will be proposed for the dose-expansion stage of the trial.
  • BLYG8824A

Eligibility Criteria

        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

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence and Nature of DLTs
Time Frame:Approximately 48 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Serum Concentration of BLYG8824A
Time Frame:At predifined interevals from Cycle 1 Day 1; Cycle 2 Day 1; Cycles ≥ 3, Day 1; Treatment Completion/ Discontinuation (Cycle length: 21 days)
Safety Issue:
Description:
Measure:Overall Response Rate (ORR)
Time Frame:Approximately 48 months
Safety Issue:
Description:ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Measure:Duration of Response (DOR)
Time Frame:Approximately 48 months
Safety Issue:
Description:Duration of response (DOR), defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
Measure:Presence of Anti-drug Antibodies (ADAs)
Time Frame:Cycle 1, Day 1; Cycle 2 Day 1; Cycles ≥ 3, Day 1; Treatment Completion/ Discontinuation (Cycle length: 21 days)
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Genentech, Inc.

Last Updated

July 8, 2020