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Protocol No. UW19075

Principal Investigator Burkard, Mark

Phase I/II

Age Group Adult

Scope National

Sponsor Type Industry

Title A Phase 1b Study to Evaluate the Safety and Clinical Activity of AB122 in Biomarker-Selected Participants with Advanced Solid Tumors

Objective The purpose of this study is to obtain information on the safety and clinical activity of AB122 in biomarker-selected participants with advanced cancer. This research study will help us understand whether AB122 can be safely given to participants with your type of cancer and selected tumor biomarkers. The biomarkers used in this study are called Tumor mutational burden high (TMB-H) or Strata Immune Signature positive. Both or one of these biomarkers may indicate response to study treatment with AB122
  • In addition, the study will look at the amount of study drug in the blood to evaluate the way thebody processes the study drug (pharmacokinetics or PK) and the way the study drug affects the growth of tumors in certain types of cancer (pharmacodynamics or PD)

  • Treatment Study treatment: There will be two visits in the first cycle (Cycle 1) and one visit every cycle thereafter. A cycle is 21 days. Dosing is every 3 weeks (Q3W)

    Description Phase 1b Study to Evaluate AB122 in Biomarker-Selected Participants with Advanced Solid Tumors

    Key Eligibility
  • Male or female at least 18 years of age or older
  • Women with no childbearing potential because of surgery or who are at least 1 year postmenopausal (ie, 12 months post last menstrual period) or with menopause confirmed by follicle-stimulating hormone testing
  • Male and Females of childbearing potential must agree to adequate birth control as defined by the protocol
  • 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
  • May have received or refused any number of prior therapies. Treatment-na├»ve participants who are ineligible for standard of care therapies are eligible to participate in this study
  • Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Prior chemotherapy or certain immune therapies (eg, tumor vaccine, cytokine, or growth factor given to control the cancer) or biologic agents must have been completed at least 4 weeks (28 days) before investigational product administration
  • Previously treated brain or meningeal metastases, must meet criteria as defined by the protocol
  • Prior radiation therapy must have been completed as defined by the protocol
  • Physiologic doses of corticosteroids less than 10 mg/day of prednisone or its equivalent may be permitted
  • Negative tests for hepatitis B surface antigen, hepatitis C virus antibody (or hepatitis C qualitative RNA), and human immunodeficiency virus (HIV)-1 and HIV-2 antibody at screening
  • Adequate organ and marrow function as defined by the protocol
    EXCLUSION
  • Use of any live attenuated vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product
  • Underlying medical conditions (eg, interstitial lung disease, active infections requiring antibiotics, recent hospitalization with unresolved symptoms, symptomatic congestive heart failure [New York Heart Association class III or IV], unstable angina, uncontrolled hypertension, cardiac arrhythmia, interstitial lung disease, active coagulopathy) 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
  • Any active or documented history of autoimmune disease or history of a syndrome that required systemic steroids or immunosuppressive medications, except for vitiligo, endocrinopathies in participants stable on hormone replacement therapy, or resolved childhood asthma/atopy. Participants with asthma requiring intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
  • Any acute gastrointestinal symptoms (eg, nausea, vomiting, diarrhea, heartburn) at the time of screening or admission
  • 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
  • Prior treatment with temozolomide
  • 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

  • Applicable Disease Sites Anal; Any Site; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Hematologic cancers, other; Ill-Defined Sites; Kidney; Liver; Lung; Lymphoma; Melanoma/Skin cancer; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

    Status Open

    Participating Institutions UW Hospital and Clinics