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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04468607
Recruitment Status : Recruiting
First Posted : July 13, 2020
Last Update Posted : November 24, 2023
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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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 metastatic colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: BLYG8824A Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
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
Actual Study Start Date : August 31, 2020
Estimated Primary Completion Date : January 2, 2026
Estimated Study Completion Date : January 2, 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose-Escalation Stage
Participants will be assigned sequentially to escalating doses of BLYG8824A, up to the maximum tolerated dose (MTD).
 Drug: BLYG8824A
BLYG8824A will be administered at a flat dose independent of body weight.
Experimental: Dose-Expansion Stage
Once 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.
 Drug: BLYG8824A
BLYG8824A will be administered at a flat dose independent of body weight.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and Nature of DLTs [ Time Frame: Approximately 48 months ]
  2. Number of Patricipants with Adverse Events [ Time Frame: Approximately 48 months ]
  3. Number Of Cycles Received [ Time Frame: Approximately 48 months ]
  4. Dose Intensity [ Time Frame: Approximately 48 months ]
  5. Maximum Tolerated Dose(s) MTD(s) of BLYG8824A [ Time Frame: Approximately 48 months ]

Secondary Outcome Measures :
  1. 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) ]
  2. Overall Response Rate (ORR) [ Time Frame: Approximately 48 months ]
    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)

  3. Duration of Response (DOR) [ Time Frame: Approximately 48 months ]
    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

  4. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04468607


Contacts
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Contact: Reference Study ID Number: GO41751 https://forpatients.roche.com/ 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Australia, Victoria
Peter MacCallum Cancer Centre; Medical Oncology Recruiting
Melbourne, Victoria, Australia, 3000
The Alfred Hospital; Malignant Haematology & Stem Cell Transplant Service Recruiting
Melbourne, Victoria, Australia, 3004
Canada, Ontario
Princess Margaret Cancer Centre; Clinical Trials Pharmacy Recruiting
Toronto, Ontario, Canada, M5G 2M9
Spain
Clinica Universitaria de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Hospital Universitario Vall d'Hebron - PPDS Recruiting
Barcelona, Spain, 08035
START Madrid-FJD, Hospital Fundacion Jimenez Diaz Recruiting
Madrid, Spain, 28040
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Genentech, Inc.
More Information
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT04468607    
Other Study ID Numbers: GO41751
First Posted: July 13, 2020    Key Record Dates
Last Update Posted: November 24, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases