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Monoclonal Antibodies
BLYG8824A for Colorectal Cancer
Phase 1
Waitlist Available
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prior disease progression (or intolerance) following oxaliplatin, irinotecan, fluoropyrimidines, and anti-EGFR monoclonal antibodies
Histologically or cytologically documented invasive CRC: incurable, unresectable, locally advanced or metastatic CRC previously treated with multimodality therapy or mCRC
Must not have
Current treatment with medications that are well known to prolong the QT interval
Leptomeningeal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 48 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called BLYG8824A to see if it is safe and effective in patients with advanced colorectal cancer. The goal is to find out if the drug can shrink tumors or stop them from growing.
Who is the study for?
This trial is for adults with advanced or metastatic colorectal cancer that's worsened after standard treatments. Participants should be in fairly good physical shape (ECOG 0-1), have measurable disease, and their body functions must meet certain standards. They can't join if they have significant liver disease, active hepatitis B or C, HIV, uncontrolled diabetes, autoimmune diseases, are pregnant/breastfeeding or planning to become pregnant soon.
What is being tested?
The study tests BLYG8824A's safety and how the body processes it. It also looks at its initial effectiveness against colorectal cancer that has spread or cannot be removed by surgery. The trial includes patients who've had previous treatments and requires tissue samples for enrollment.
What are the potential side effects?
While specific side effects of BLYG8824A aren't listed here, common ones for cancer drugs include fatigue, nausea, diarrhea, blood count changes increasing infection risk; organ inflammation; allergic reactions; and possibly effects on heart rhythm.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition worsened or I couldn't tolerate treatments including oxaliplatin and anti-EGFR.
Select...
My colorectal cancer is advanced or has spread and was confirmed by a lab test.
Select...
My colorectal cancer worsened during or after my last treatment.
Select...
I agree to have biopsies before and during treatment if my tumor can be safely accessed.
Select...
I am fully active or can carry out light work.
Select...
My cancer is not highly mutated (MSS or MSI-L).
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My cancer can be measured and tracked using scans.
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My colorectal cancer has returned or isn't responding to treatment and has spread.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am taking medication that can affect my heart's rhythm.
Select...
My cancer has spread to the lining of my brain and spinal cord.
Select...
My spinal cord compression hasn't been treated with surgery or radiation.
Select...
I have had a previous transplant of stem cells or an organ.
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I have hepatitis C.
Select...
I have a significant liver condition.
Select...
I do not have major heart or lung problems.
Select...
I have a brain tumor or cancer that has spread to my brain and it's not being treated.
Select...
I am HIV positive.
Select...
My Type 2 diabetes is not well-managed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 48 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Duration of Response (DOR)
Overall Response Rate (ORR)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose-Expansion StageExperimental Treatment1 Intervention
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.
Group II: Dose-Escalation StageExperimental Treatment1 Intervention
Participants will be assigned sequentially to escalating doses of BLYG8824A, up to the maximum tolerated dose (MTD).
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for colorectal cancer include targeted therapies and immunotherapies. Targeted therapies, such as EGFR inhibitors (cetuximab) and VEGF inhibitors (bevacizumab), work by specifically targeting cancer cell markers or pathways to inhibit tumor growth and spread.
Immunotherapies, like checkpoint inhibitors (pembrolizumab), enhance the body's immune response to recognize and destroy cancer cells. These treatments are important for colorectal cancer patients as they offer more personalized and potentially more effective options with fewer side effects compared to traditional chemotherapy.
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Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,563 Previous Clinical Trials
569,969 Total Patients Enrolled
Clinical TrialsStudy DirectorGenentech, Inc.
2,227 Previous Clinical Trials
896,302 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking medication that can affect my heart's rhythm.I can provide a tissue sample for the study, either from previous or new biopsies.My condition worsened or I couldn't tolerate treatments including oxaliplatin and anti-EGFR.My cancer has spread to the lining of my brain and spinal cord.Any severe side effects from my previous treatments have mostly gone away.My colorectal cancer is advanced or has spread and was confirmed by a lab test.My spinal cord compression hasn't been treated with surgery or radiation.My cancer can be measured by standard criteria or is evaluable for treatment.My colorectal cancer worsened during or after my last treatment.I have had a previous transplant of stem cells or an organ.I have hepatitis C.I have a significant liver condition.I do not have major heart or lung problems.I agree to have biopsies before and during treatment if my tumor can be safely accessed.I am fully active or can carry out light work.My cancer is not highly mutated (MSS or MSI-L).I have a brain tumor or cancer that has spread to my brain and it's not being treated.My blood and organs are functioning well.My cancer can be measured and tracked using scans.You have a previous medical history of an autoimmune disease.My colorectal cancer has returned or isn't responding to treatment and has spread.I am HIV positive.My Type 2 diabetes is not well-managed.You are expected to live for at least 12 more weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Dose-Escalation Stage
- Group 2: Dose-Expansion Stage
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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