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A Phase 1b Study to Evaluate the Safety and Clinical Activity of AB122 in Biomarker-Selected Participants with Advanced Solid Tumors
Overall Recruitment Status: Active, enrollment completed
 
Official Title
A Phase 1b Study to Evaluate the Safety and Clinical Activity of AB122 in Biomarker-Selected Participants with Advanced Solid Tumors
 
Region Sponsors
Mid-Atlantic
Arcus Biosciences, Inc.
 
Acronym KP IRB No.
1528992
 
Study Type Phase
Clinical Trial Phase I
 
Study Population Description
 
Purpose
The purpose of this study is to evaluate the safety and clinical activity of Zimberelimab (AB122) in biomarker-selected participants with advanced solid tumors.
 
Detailed Description
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • 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 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.
 
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 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.

 
Keywords and/or Specific Medical Conditions
  • Advanced Solid Tumors
  • Strata Immune Signature
  • Oncology (Adult)
  • TMB-H
 
KP Clinical Facility
  • Gaithersburg Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Leon Hwang, MD
Contact Information:
- Leslie Greenberg, MS, RN
-Gaithersburg Medical Center


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