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

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ClinicalTrials.gov Identifier: NCT04087018
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
Strata Oncology
Information provided by (Responsible Party):
Arcus Biosciences, Inc.

Brief Summary:
This is a Phase 1b open-label study to evaluate the safety and clinical activity of AB122 in biomarker-selected participants with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: AB122 Phase 1

Detailed Description:
AB122 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Study to Evaluate the Safety and Clinical Activity of AB122 in Biomarker-Selected Participants With Advanced Solid Tumors
Actual Study Start Date : September 24, 2019
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : December 30, 2021

Arm Intervention/treatment
Experimental: TMB-H
Participants with a tumor biomarker status of TMB-H will receive AB122 every 3 weeks.
Drug: AB122
AB122 is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1. Participants in each cohort will receive AB122 intravenously Q3W. Treatment will continue until progressive disease, unacceptable toxicity, withdrawal of consent, or other reasons for which investigational product discontinuation occurs.

Experimental: Strata Immune Signature positive
Participants with a tumor biomarker status Strata Immune Signature positive will receive AB122 every 3 weeks.
Drug: AB122
AB122 is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1. Participants in each cohort will receive AB122 intravenously Q3W. Treatment will continue until progressive disease, unacceptable toxicity, withdrawal of consent, or other reasons for which investigational product discontinuation occurs.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087018


Contacts
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Contact: Medical Director 510-694-6200 ClinicalTrialInquiry@arcusbio.com

Locations
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United States, Wisconsin
United States, Wisconsin Recruiting
Madison, Wisconsin, United States, 53705
Contact: Principal Investigator         
Principal Investigator: Principal Investigator         
Sponsors and Collaborators
Arcus Biosciences, Inc.
Strata Oncology
Investigators
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Study Director: Medical Director Arcus Biosciences, Inc.

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Responsible Party: Arcus Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT04087018     History of Changes
Other Study ID Numbers: AB122CSP0002
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms