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
Summary
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.
Arms & interventions
- DrugRO7566802
RO7566802 solution for infusion will be administered as specified in each treatment arm.
- DrugAtezolizumab
Atezolizumab solution for infusion will be administered as specified in each treatment arm.
Outcome measures
Primary
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
Secondary
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
Eligibility criteria
Study locations (6)
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35233
Yale Cancer Center
New Haven, Connecticut, 06520
Icahn School of Medicine at Mount Sinai (ISMMS)
New York, New York, 10029
The Ohio State University
Columbus, Ohio, 43221-3502
Magee-Woman's Hospital
Harrisburg, Pennsylvania, 17109
SCRI Oncology Partners
Nashville, Tennessee, 37203