Study to Evaluate Safety and Clinical Activity of AB122 in Biomarker Selected Participants With Advanced Solid Tumors

NCT ID: NCT04087018

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-24
• Study Completion Date: 2024-06-17

Brief Summary

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.

Detailed Description

The activity of zimberelimab every 3 weeks (Q3W) will be evaluated in molecularly defined patient populations as described by the StrataNGS test (to be performed outside of this study protocol). Participants with any advanced tumor type will be stratified evenly by tumor biomarker status as follows: TMB-H or Strata Immune Signature positive. Each cohort may enroll approximately 40 participants. Following completion of and/or discontinuation from investigational product and follow-up, all participants will be followed for survival.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TMB-H

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

Group Type: EXPERIMENTAL

zimberelimab

Intervention Type: DRUG

zimberelimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1. Participants in each cohort will receive zimberelimab intravenously Q3W. Treatment will continue until progressive disease, unacceptable toxicity, withdrawal of consent, or other reasons for which investigational product discontinuation occurs.

Strata Immune Signature positive

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

Group Type: EXPERIMENTAL

zimberelimab

Intervention Type: DRUG

zimberelimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1. Participants in each cohort will receive zimberelimab intravenously Q3W. Treatment will continue until progressive disease, unacceptable toxicity, withdrawal of consent, or other reasons for which investigational product discontinuation occurs.

Interventions

zimberelimab

zimberelimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1. Participants in each cohort will receive zimberelimab intravenously Q3W. Treatment will continue until progressive disease, unacceptable toxicity, withdrawal of consent, or other reasons for which investigational product discontinuation occurs.

Intervention Type: DRUG

Other Intervention Names

AB122

Eligibility Criteria

Inclusion Criteria

• Capable of giving signed informed consent.
• Male or female participants ≥ 18 years of age at the time of screening.
• Negative serum pregnancy test at screening and negative serum or urine pregnancy test every 3 months during the treatment period (women of childbearing potential only).
• Pathologically confirmed tumor that is metastatic, advanced, or recurrent with progression for which no alternative known to improve survival or curative therapy exists. Tumors must be TMB-H or Strata Immune Signature positive.
• Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The measurable lesion must be outside of a radiation field if the participant received prior radiation.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• 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.
• Previously treated brain or meningeal metastases with no evidence of progression by magnetic resonance imaging (MRI) for at least 4 weeks (28 days) prior to the first dose.
• Immunosuppressive doses of systemic medications, such as corticosteroids or absorbed topical corticosteroids (doses > 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks (14 days) before investigational product administration. Physiologic doses of corticosteroids < 10 mg/day of prednisone or its equivalent may be permitted
• Prior surgery that required general anesthesia or other major surgery as defined by the Investigator must be completed at least 4 weeks before investigational product administration
• 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
• Adequate organ and marrow function

Exclusion Criteria

• Use of any live attenuated vaccines against infectious diseases within 4 weeks (28 days) of initiation of investigational product.
• Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of investigational product hazardous or obscure the interpretation of toxicity determination or Adverse events (AEs).
• History of myocardial infarction within 6 months or history of arterial thromboembolic event within 3 months of the first dose of investigational agent.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 90 days after the last dose of investigational product.
• Any active or documented history of autoimmune disease or history of a syndrome that required systemic steroids or immunosuppressive medications.
• Any acute gastrointestinal symptoms at the time of screening or admission.
• Prior malignancy active within the previous year except for locally curable cancers that have been apparently cured.
• Prior treatment with an anti-PD-L1 or anti-PD-1 as monotherapy or in combination.
• Prior treatment with temozolomide.
• Use of other investigational drugs (drugs not marketed for any indication) within 28 days or at least 5 half-lives (whichever is longer) before investigational product administration.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Strata Oncology

INDUSTRY

Sponsor Role: collaborator

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Arcus Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Arcus Biosciences, Inc.

Locations

Southern California Permanente Medical Group

Riverside, California, United States

Kaiser Permanente (NorCal) - Roseville

Roseville, California, United States

Christiana Care Health System - Helen F. Graham Cancer Center

Newark, Delaware, United States

Kaiser Permanente Mid-Atlantic

Gaithersburg, Maryland, United States

Metro MN CCOP

Saint Louis Park, Minnesota, United States

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

Prisma Health

Greenville, South Carolina, United States

Saint Francis Cancer Center

Greenville, South Carolina, United States

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Countries

United States

Related Links

https://trials.arcusbio.com/study/?id=AB122CSP0002

AB122CSP0002 - Public website

Other Identifiers

AB122CSP0002

Identifier Type: -

Identifier Source: org_study_id