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

Completed · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT04087018

Run by

Arcus Biosciences, Inc.

People needed

18

Starts

2019-09-24

Expected to finish

2024-06-17

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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