Colorectal Cancer Clinical Trial
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
Verified date | June 2024 |
Source | Genentech, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 120 |
Est. completion date | January 2, 2026 |
Est. primary completion date | January 2, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Peter MacCallum Cancer Centre; Medical Oncology | Melbourne | Victoria |
Spain | Hospital Universitario Vall d'Hebron - PPDS | Barcelona | |
Spain | START Madrid-FJD, Hospital Fundacion Jimenez Diaz | Madrid | |
Spain | Clinica Universitaria de Navarra | Pamplona | Navarra |
United States | City of Hope | Duarte | California |
United States | SCRI Oncology Partners | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Genentech, Inc. |
United States, Australia, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence and Nature of DLTs | Approximately 48 months | ||
Primary | Number of Patricipants with Adverse Events | Approximately 48 months | ||
Primary | Number Of Cycles Received | Approximately 48 months | ||
Primary | Dose Intensity | Approximately 48 months | ||
Primary | Maximum Tolerated Dose(s) MTD(s) of BLYG8824A | Approximately 48 months | ||
Secondary | Serum Concentration of BLYG8824A | At predifined interevals from Cycle 1 Day 1; Cycle 2 Day 1; Cycles = 3, Day 1; Treatment Completion/ Discontinuation (Cycle length: 21 days) | ||
Secondary | Overall Response Rate (ORR) | 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) | Approximately 48 months | |
Secondary | Duration of Response (DOR) | 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 | Approximately 48 months | |
Secondary | Presence of Anti-drug Antibodies (ADAs) | Cycle 1, Day 1; Cycle 2 Day 1; Cycles = 3, Day 1; Treatment Completion/ Discontinuation (Cycle length: 21 days) |
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