Skip to Main Content
Phase I

A Phase I, Open-Label, Multicenter, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

  • Study HIC#:2000035797
  • Last Updated:10/02/2025

This is a first-in-human Phase I, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic, and preliminary anti-tumor activity of RO7566802 as a single agent and in combination with atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Participants will be enrolled in 2 stages: dose escalation and expansion.

    Contact Us

    For more information about this study, including how to volunteer, contact:

    Ingrid Palma

    Help Us Discover!

    You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.

    Eligibility Criteria

    Inclusion Criteria:

    • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
    • Life expectancy >=3 months, in the investigator's judgment
    • Adequate hematologic and end-organ function
    • Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy that has progressed after available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care
    • Measurable disease per RECIST v1.1
    • Tumor specimen availability, for certain cohorts

    Exclusion Criteria:

    • Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to C1D1, with certain exceptions
    • Active hepatitis B or C
    • Active tuberculosis
    • Positive test for HIV infection
    • Administration of a live, attenuated vaccine (e.g., Flumist) within 4 weeks prior to RO7566802 infusion
    • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
    • Active or history of autoimmune disease
    • Prior allogeneic stem cell or organ transplantation
    • Uncontrolled tumor-related pain
    • Significant cardiovascular disease

    Other protocol-defined inclusion/exclusion criteria may apply.

    Principal Investigator

    Sub-Investigators

    For more information about this study, including how to volunteer, contact: