Zimberelimab for Solid Tumors

Recruiting at 21 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Arcus Biosciences, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a Phase 1b open-label study to evaluate the safety and clinical activity of zimberelimab (AB122) in biomarker-selected participants with advanced solid tumors.

Research Team

Medical Director

Principal Investigator

Arcus Biosciences, Inc.

Eligibility Criteria

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.

Inclusion Criteria

I finished my last cancer treatment at least 4 weeks ago and any side effects have stabilized.

Negative tests for hepatitis B surface antigen, hepatitis C virus antibody (or hepatitis C qualitative ribonucleic acid [RNA; qualitative]), and human immunodeficiency virus (HIV)-1 and HIV-2 antibody at screening

My brain cancer has not worsened in the last 4 weeks according to MRI results.

Exclusion Criteria

I have not received any live vaccines in the last 4 weeks.

I have been treated with temozolomide before.

I have been treated with anti-PD-L1 or anti-PD-1 therapy before.

Treatment Details

Interventions

• Zimberelimab (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: TMB-H Experimental Treatment 1 Intervention

Participants with a tumor biomarker status of TMB-H will receive zimberelimab every 3 weeks.

Group II: Strata Immune Signature positive Experimental Treatment 1 Intervention

Participants with a tumor biomarker status Strata Immune Signature positive will receive zimberelimab every 3 weeks.

Who Is Running the Clinical Trial?

Arcus Biosciences, Inc.

Lead Sponsor

Trials

44

Recruited

7,500+

Strata Oncology

Industry Sponsor

Trials

6

Recruited

58,700+

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine