What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, particularly targeted therapies and immunotherapies similar to BLYG8824A, often include agents like cetuximab and bevacizumab. These treatments can cause a range of side effects. Cetuximab is associated with skin reactions, such as acneiform rash, and ocular toxicities like trichomegaly and keratitis. Bevacizumab can lead to hypertension, bleeding, and, in rare cases, intestinal perforation. Both therapies may also cause infusion-related reactions. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Several targeted therapies and immunotherapies have been approved by the FDA for the treatment of colorectal cancer. Notable examples include cetuximab, a monoclonal antibody targeting the epidermal growth factor receptor (EGFR), and bevacizumab, which targets vascular endothelial growth factor (VEGF). Additionally, pembrolizumab and nivolumab, both immune checkpoint inhibitors targeting PD-1, have been approved for microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancers. These treatments, like BLYG8824A, aim to inhibit tumor growth through specific molecular targets or by enhancing the immune system's ability to fight cancer.

What other types of research exist?

Promising novel alternatives to BLYG8824A for colorectal cancer patients in 2024 include: 1) Pembrolizumab (a PD-1 inhibitor) for MSI-H or dMMR tumors, 2) Nivolumab (another PD-1 inhibitor) often used in combination with Ipilimumab (a CTLA-4 inhibitor) for MSI-H or dMMR tumors, 3) Encorafenib (a BRAF inhibitor) combined with Cetuximab (an EGFR inhibitor) for BRAF V600E-mutant metastatic colorectal cancer, and 4) Trastuzumab deruxtecan (an antibody-drug conjugate) for HER2-positive metastatic colorectal cancer. These therapies have shown significant efficacy in clinical trials and are considered promising options for targeted and immunotherapy in colorectal cancer.

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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 below

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My condition worsened or I couldn't tolerate treatments including oxaliplatin and anti-EGFR.

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My colorectal cancer is advanced or has spread and was confirmed by a lab test.

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My colorectal cancer worsened during or after my last treatment.

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I agree to have biopsies before and during treatment if my tumor can be safely accessed.

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I am fully active or can carry out light work.

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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:

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I am taking medication that can affect my heart's rhythm.

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My cancer has spread to the lining of my brain and spinal cord.

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My spinal cord compression hasn't been treated with surgery or radiation.

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I have had a previous transplant of stem cells or an organ.

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I have hepatitis C.

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I have a significant liver condition.

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I do not have major heart or lung problems.

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I have a brain tumor or cancer that has spread to my brain and it's not being treated.

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I am HIV positive.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 48 months for reporting.

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).

0 / 18Eligibility criteria met

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.