Status:
COMPLETED
Study to Evaluate Safety and Clinical Activity of AB122 in Biomarker Selected Participants With Advanced Solid Tumors
Lead Sponsor:
Arcus Biosciences, Inc.
Collaborating Sponsors:
Strata Oncology
Gilead Sciences
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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). Parti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04087018
Start Date
September 24 2019
End Date
June 17 2024
Last Update
September 19 2024
Active Locations (9)
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1
Southern California Permanente Medical Group
Riverside, California, United States, 92120
2
Kaiser Permanente (NorCal) - Roseville
Roseville, California, United States, 95661
3
Christiana Care Health System - Helen F. Graham Cancer Center
Newark, Delaware, United States, 19713
4
Kaiser Permanente Mid-Atlantic
Gaithersburg, Maryland, United States, 20879