A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies

Overview

This is a Phase 1/1b, multicenter, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of AB308 in combination with zimberelimab (AB122) in participants with advanced malignancies.

SparkCures ID 1149
Trial Phase Phase 1
Enrollment 94 Patients
Treatments
Tags
Trial Sponsors
  • Arcus Biosciences, Inc.
Trial Collaborators
  • Gilead Sciences
NCT Identifier

NCT04772989

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Performance status score of 0 or 1
  • Measurable disease as per radiographic evaluation
  • Disease-specific criteria for dose escalation:
    • Participants with any type of solid tumor for which no treatment is currently available, or
    • Participants with non-Hodgkin Lymphoma that has progressed on prior chemotherapy and unable to receive stem cell transplant or adoptive cell transfer
    • Participants may have received up to 5 prior anti-cancer therapies and an unlimited number of prior hormonal therapies.
  • Disease-specific criteria for dose-expansion Cohort 1:
    • Participants with previously untreated locally advanced or metastatic NSCLC with a high PD-L1 expression
  • Disease-specific criteria for dose-expansion Cohort 2:
    • Participants with metastatic melanoma with at least one prior anti-cancer therapy and progression after PD-L1 therapy
  • Disease-specific criteria for dose-expansion Cohort 3:
    • Participants with metastatic gastric, or gastroesophageal junction, or esophageal cancer with at least 1 prior chemotherapy and no prior PD-(L)1 therapy.
  • Disease-specific criteria for dose-expansion Cohort 4:
    • Participants with metastatic cervical cancer with at least 1 prior chemotherapy and no prior PD-(L)1 therapy.
  • Disease-specific criteria for dose-expansion Cohort 5:
    • Participants with diffuse large B-cell lymphoma (DLBCL) with at least 2 prior anti-cancer therapies and unable to receive stem cell transplant or adoptive cell transfer, or
    • Participants with multiple myeloma with at least 3 prior anti-cancer therapies and for whom no treatment is currently available.

Exclusion Criteria:

  • History of trauma or major surgery within 28 days prior to the first dose of study treatment.
  • Prior treatment with an anti-TIGIT antibody.
  • Any active or prior autoimmune disease that required treatment within 3 years of the first dose of study treatment.
  • Prior chemotherapy, targeted small-molecule therapy, immunotherapy, or biologic agents, or use of other investigational drugs within 28 days before first dose of study treatment.
  • Discontinued prior immunotherapy for immune related adverse events with a high severity.

 

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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