Clinical Trials /

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

NCT04087018

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study to Evaluate Safety and Clinical Activity of AB122 in Biomarker Selected Participants With Advanced Solid Tumors
  • Official Title: A Phase 1b Study to Evaluate the Safety and Clinical Activity of AB122 in Biomarker-Selected Participants With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: AB122CSP0002
  • NCT ID: NCT04087018

Conditions

  • Advanced Solid Tumors

Interventions

DrugSynonymsArms
AB122TMB-H

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
TMB-HExperimentalParticipants with a tumor biomarker status of TMB-H will receive AB122 every 3 weeks.
  • AB122
Strata Immune Signature positiveExperimentalParticipants with a tumor biomarker status Strata Immune Signature positive will receive AB122 every 3 weeks.
  • AB122

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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)
Safety Issue:
Description: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

Measure: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.
Safety Issue:
Description:Number of Participants Treated with AB122 with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
Measure: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)
Safety Issue:
Description:The time from first documentation of disease response (CR or PR) until first documentation of progressive disease.
Measure: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)
Safety Issue:
Description:The time from treatment initiation to confirmed best overall response of CR or PR.
Measure:Disease control rate at 6 months (DCR6)
Time Frame:6 Months
Safety Issue:
Description:Number of Participants with Complete Response, Partial Response, or Stable Disease for Greater Than 6 Months per RECIST v1.1
Measure:Progression-free survival at 6 (PFS6)
Time Frame:6 Months
Safety Issue:
Description:The percentage of Participants Without Disease Progression per RECIST v1.1 and iRECIST at 6 months
Measure:Progression-free survival at 12 months (PFS12)
Time Frame:12 Months
Safety Issue:
Description:The percentage of Participants Without Disease Progression per RECIST v1.1 and iRECIST at 12 months
Measure:Overall survival at 12 months (OS12)
Time Frame:12 Months
Safety Issue:
Description:The percentage of participants who are alive at 12 months based on first dose to date of death.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Arcus Biosciences, Inc.

Last Updated