NCT04468607CompletedPhase 1
A Study of BLYG8824A in Participants With Locally Advanced or Metastatic Colorectal Cancer
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
Source: ClinicalTrials.gov · Last updated 25 Apr 2025
Brief summary (registry, in English)
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 (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 46 (actual)
- First submitted
- 23 Jun 2020
- Start date
- 31 Aug 2020
- Primary completion date
- 16 Oct 2024
- Lead sponsor
- Genentech, Inc.
- Diseases
- Colorectal cancer
- NCT number
- NCT04468607
- EU CT number
- 2023-503409-12-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 46
- From 31 Aug 2020 to the primary completion date, 16 Oct 2024
- 6 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Spinal cord compression that has not been definitively treated with surgery and/or radiation
- Prior allogeneic stem cell or solid organ transplantation
Other illness
- 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
- Primary CNS malignancy, untreated CNS metastases, or active CNS metastases
- Leptomeningeal disease
- History of autoimmune disease
Lab values
- Current treatment with medications that are well known to prolong the QT interval
Other
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 4 months after the final dose of BLYG8824A
- Significant cardiopulmonary dysfunction
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Hospital Universitario Vall d'Hebron - PPDS Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| START Madrid-FJD, Hospital Fundacion Jimenez Diaz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Clinica Universitaria de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.