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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04087018
Recruitment Status : Active, not recruiting
First Posted : September 12, 2019
Last Update Posted : October 25, 2021
Sponsor:
Collaborator:
Strata Oncology
Information provided by (Responsible Party):
Arcus Biosciences, Inc.

Tracking Information
First Submitted Date  ICMJE August 29, 2019
First Posted Date  ICMJE September 12, 2019
Last Update Posted Date October 25, 2021
Actual Study Start Date  ICMJE September 24, 2019
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2019)
Objective response Rate (ORR) [ Time Frame: Change from baseline assessed at week 6, 12, 18 and then every 9 weeks thereafter until disease progression, approximately 12 months (however can be longer) ]
Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Tumor assessments over time will be measured using RECIST v1.1
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2021)
  • Number of Participants with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0 [ Time Frame: From screening until 90 days after the last dose of investigational product or until initiation of a new systemic anticancer therapy, whichever occurs first. ]
    Number of Participants Treated with zimberelimab with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
  • Duration of response (DoR) [ Time Frame: From the date of initiation of treatment until the date of first documented progression, through completion of the study, approximately 12 months (however may be longer) ]
    The time from first documentation of disease response (CR or PR) until first documentation of progressive disease.
  • Time to response (TTR) [ Time Frame: From the date of initiation of treatment until the date of first documented response, through completion of the study, approximately 12 months (however may be longer) ]
    The time from treatment initiation to confirmed best overall response of CR or PR.
  • Disease control rate at 6 months (DCR6) [ Time Frame: 6 Months ]
    Number of Participants with Complete Response, Partial Response, or Stable Disease for Greater Than 6 Months per RECIST v1.1
  • Progression-free survival at 6 (PFS6) [ Time Frame: 6 Months ]
    The percentage of Participants Without Disease Progression per RECIST v1.1 and iRECIST at 6 months
  • Progression-free survival at 12 months (PFS12) [ Time Frame: 12 Months ]
    The percentage of Participants Without Disease Progression per RECIST v1.1 and iRECIST at 12 months
  • Overall survival at 12 months (OS12) [ Time Frame: 12 Months ]
    The percentage of participants who are alive at 12 months based on first dose to date of death.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2019)
  • Number of Participants with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0 [ Time Frame: From screening until 90 days after the last dose of investigational product or until initiation of a new systemic anticancer therapy, whichever occurs first. ]
    Number of Participants Treated with AB122 with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
  • Duration of response (DoR) [ Time Frame: From the date of initiation of treatment until the date of first documented progression, through completion of the study, approximately 12 months (however may be longer) ]
    The time from first documentation of disease response (CR or PR) until first documentation of progressive disease.
  • Time to response (TTR) [ Time Frame: From the date of initiation of treatment until the date of first documented response, through completion of the study, approximately 12 months (however may be longer) ]
    The time from treatment initiation to confirmed best overall response of CR or PR.
  • Disease control rate at 6 months (DCR6) [ Time Frame: 6 Months ]
    Number of Participants with Complete Response, Partial Response, or Stable Disease for Greater Than 6 Months per RECIST v1.1
  • Progression-free survival at 6 (PFS6) [ Time Frame: 6 Months ]
    The percentage of Participants Without Disease Progression per RECIST v1.1 and iRECIST at 6 months
  • Progression-free survival at 12 months (PFS12) [ Time Frame: 12 Months ]
    The percentage of Participants Without Disease Progression per RECIST v1.1 and iRECIST at 12 months
  • Overall survival at 12 months (OS12) [ Time Frame: 12 Months ]
    The percentage of participants who are alive at 12 months based on first dose to date of death.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Safety and Clinical Activity of AB122 in Biomarker Selected Participants With Advanced Solid Tumors
Official Title  ICMJE A Phase 1b Study to Evaluate the Safety and Clinical Activity of AB122 in Biomarker-Selected Participants With Advanced Solid Tumors
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE Drug: 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.
Other Name: AB122
Study Arms  ICMJE
  • Experimental: TMB-H
    Participants with a tumor biomarker status of TMB-H will receive zimberelimab every 3 weeks.
    Intervention: Drug: zimberelimab
  • Experimental: Strata Immune Signature positive
    Participants with a tumor biomarker status Strata Immune Signature positive will receive zimberelimab every 3 weeks.
    Intervention: Drug: zimberelimab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 10, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 28, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Capable of giving signed informed consent.
  2. Male or female participants ≥ 18 years of age at the time of screening.
  3. 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).
  4. 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.
  5. 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.
  6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  7. 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.
  8. 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.
  9. 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
  10. 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
  11. 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
  12. Adequate organ and marrow function

Exclusion Criteria:

  1. Use of any live attenuated vaccines against infectious diseases within 4 weeks (28 days) of initiation of investigational product.
  2. 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.
  3. History of myocardial infarction within 6 months or history of arterial thromboembolic event within 3 months of the first dose of investigational agent.
  4. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  5. 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.
  6. Any active or documented history of autoimmune disease or history of a syndrome that required systemic steroids or immunosuppressive medications.
  7. Any acute gastrointestinal symptoms at the time of screening or admission.
  8. Prior malignancy active within the previous year except for locally curable cancers that have been apparently cured.
  9. Prior treatment with an anti-PD-L1, anti-PD-1, anti-CTLA-4, or other immune checkpoint inhibitor or agonist as monotherapy or in combination.
  10. Prior treatment with temozolomide.
  11. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04087018
Other Study ID Numbers  ICMJE AB122CSP0002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Arcus Biosciences, Inc.
Study Sponsor  ICMJE Arcus Biosciences, Inc.
Collaborators  ICMJE Strata Oncology
Investigators  ICMJE
Study Director: Medical Director Arcus Biosciences, Inc.
PRS Account Arcus Biosciences, Inc.
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP