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Monoclonal Antibodies

Zimberelimab for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Arcus Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prior chemotherapy or certain immune therapies or biologic agents must have been completed at least 4 weeks (28 days) before investigational product administration and all AEs have either returned to baseline or stabilized
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective for treating advanced solid tumors.

Who is the study for?
Adults over 18 with advanced solid tumors that are biomarker-positive for TMB-H or Strata Immune Signature, who have at least one measurable lesion. They must not be on high-dose steroids, have untreated brain metastases, active infections like hepatitis or HIV, a recent history of heart attack or stroke, autoimmune diseases requiring treatment, acute GI symptoms, other cancers within the last year (except curable types), prior anti-PD-L1/PD-1 therapy or temozolomide use.Check my eligibility
What is being tested?
The trial is testing zimberelimab (AB122) in patients with specific biomarkers and advanced solid tumors. It's an open-label Phase 1b study focusing on safety and how well the drug works. Participants will receive AB122 to see if it helps control their tumor growth.See study design
What are the potential side effects?
Zimberelimab may cause immune-related side effects such as inflammation in various organs including the intestines and lungs, skin reactions, hormone gland problems like thyroid disorders; fatigue; infusion reactions; possible increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I finished my last cancer treatment at least 4 weeks ago and any side effects have stabilized.
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I am fully active or can carry out light work.
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My brain cancer has not worsened in the last 4 weeks according to MRI results.
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My cancer has spread, cannot be cured by known treatments, and is TMB-H or immune signature positive.
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I am 18 years old or older.
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I am able to understand and sign the consent form.
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I had major surgery with general anesthesia over 4 weeks ago.
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I stopped taking high doses of steroids or similar medicines more than 2 weeks ago.
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I have at least one tumor that can be measured and it's not in an area treated with radiation.
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My organs and bone marrow are working well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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
Objective response Rate (ORR)
Secondary outcome measures
Disease control rate at 6 months (DCR6)
Duration of response (DoR)
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: TMB-HExperimental Treatment1 Intervention
Participants with a tumor biomarker status of TMB-H will receive zimberelimab every 3 weeks.
Group II: Strata Immune Signature positiveExperimental Treatment1 Intervention
Participants with a tumor biomarker status Strata Immune Signature positive will receive zimberelimab every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
zimberelimab
2022
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Strata OncologyIndustry Sponsor
5 Previous Clinical Trials
600,856 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,077 Previous Clinical Trials
836,932 Total Patients Enrolled
Arcus Biosciences, Inc.Lead Sponsor
41 Previous Clinical Trials
5,888 Total Patients Enrolled

Media Library

Zimberelimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04087018 — Phase 1
Solid Tumors Research Study Groups: Strata Immune Signature positive, TMB-H
Solid Tumors Clinical Trial 2023: Zimberelimab Highlights & Side Effects. Trial Name: NCT04087018 — Phase 1
Zimberelimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04087018 — Phase 1

Frequently Asked Questions

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

How widespread is this experiment's implementation?

"This clinical trial is currently running in seventeen different medical centres, including Gunderson Lutheran Medical Center (La Crosse), Southern California Permanente Medical Group (Riverside) and Kaiser Permanente (NorCal) - Roseville. The remaining fourteen sites are located across the country."

Answered by AI

Are there still opportunities to participate in this scientific experiment?

"Per information available on clinicaltrials.gov, this research project is not currently seeking out participants. The trial was first published in September 2019 and last updated in October 2022; however, there are 2502 other trials which have ongoing recruitment efforts at present."

Answered by AI

What are the potential risks associated with zimberelimab?

"With limited data confirming its efficacy and safety, zimberelimab received a score of 1 on our team's scale. Since this is only a Phase 1 trial, further research will be needed to confirm these results."

Answered by AI
~2 spots leftby Sep 2024