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.
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
Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to Cycle 1 Day 1, with certain exceptions
Active hepatitis B or C
Active tuberculosis
Positive test for human immunodeficiency virus (HIV) infection
Sequential
RO7566802
DrugRO7566802 solution for infusion will be administered as specified in each treatment arm.
Atezolizumab
DrugAtezolizumab solution for infusion will be administered as specified in each treatment arm.
Number of Participants with Dose-limiting Toxicity (DLTs)
Percentage of Participants with Adverse Events (AEs) Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
Area Under the Serum Concentration Time Curve (AUC) of RO7566802
Maximum Serum Concentration (Cmax) of RO7566802
Minimum Serum Concentration (Cmin) of RO7566802
Total Clearance (CL) of RO7566802
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