← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 48 months

Awards & highlights

Study Summary

This trial will study a new drug for safety and how well it works in treating colorectal cancer.

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.Check my eligibility

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.See study design

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

Select...

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).

Select...

My cancer can be measured and tracked using scans.

Select...

My colorectal cancer has returned or isn't responding to treatment and has spread.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose Intensity

Incidence and Nature of DLTs

Maximum Tolerated Dose(s) MTD(s) of BLYG8824A

+2 more

Secondary outcome measures

Duration of Response (DOR)

Overall Response Rate (ORR)

Presence of Anti-drug Antibodies (ADAs)

+1 more

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 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor

1,541 Previous Clinical Trials

567,971 Total Patients Enrolled

Clinical TrialsStudy DirectorGenentech, Inc.

2,201 Previous Clinical Trials

888,483 Total Patients Enrolled

Media Library

BLYG8824A (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04468607 — Phase 1

Colorectal Cancer Research Study Groups: Dose-Escalation Stage, Dose-Expansion Stage

Colorectal Cancer Clinical Trial 2023: BLYG8824A Highlights & Side Effects. Trial Name: NCT04468607 — Phase 1

BLYG8824A (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04468607 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for individuals to participate in this clinical investigation?

"Affirmative. The clinical trial records hosted on clinicaltrials.gov indicate that the study, which first appeared online on August 31st 2020, is actively seeking participants. Altogether, 120 patients need to be recruited from two different medical centres."

Answered by AI

Has the FDA validated BLYG8824A for public consumption?

"The safety of BLYG8824A is tentatively rated at a 1, due to the paucity of data available from its Phase 1 trial."

Answered by AI

What is the size of the sample population engaging in this research?

"Affirmative. Clinicaltrials.gov posts that this medical research has been active since August 31st 2020 and is still recruiting patients, with the goal of enrolling 120 individuals from two sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "A Study of BLYG8824A in Participants With Locally Advanced or Metastatic Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04468607.

All > Colorectal Cancer Ventura