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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
RO7566802 solution for infusion will be administered as specified in each treatment arm.
Atezolizumab solution for infusion will be administered as specified in each treatment arm.
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
Yale Cancer Center
New Haven, Connecticut, United States
Icahn School of Medicine at Mount Sinai (ISMMS)
New York, New York, United States
The Ohio State University
Columbus, Ohio, United States
Magee-Woman's Hospital
Harrisburg, Pennsylvania, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
British Columbia Cancer Agency - 600 10th Ave W
Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
...and 8 more locations
Number of Participants with Dose-limiting Toxicity (DLTs)
Time frame: Cycle 1 Day 1 through 21 days after Cycle 2 Day 1 (Cycle length=21 days) (up to approximately 42 days)
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)
Time frame: Up to approximately 4 years
Area Under the Serum Concentration Time Curve (AUC) of RO7566802
Time frame: Up to approximately 4 years
Maximum Serum Concentration (Cmax) of RO7566802
Time frame: Up to approximately 4 years
Minimum Serum Concentration (Cmin) of RO7566802
Time frame: Up to approximately 4 years
Total Clearance (CL) of RO7566802
Time frame: Up to approximately 4 years
Volume of Distribution at Steady State (Vss) of RO7566802
Time frame: Up to approximately 4 years
Serum Concentration of Atezolizumab
Time frame: Up to approximately 4 years
Objective Response Rate as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time frame: Up to approximately 4 years
Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7566802
Time frame: From Baseline up to approximately 4 years
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