This is a first-in-human Phase Ia/Ib, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of RO7759065 as a single agent (Phase Ia) or in combination with atezolizumab (Phase Ib) in patients with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Several key aspects of the study design and study population are summarized below.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Specified dose on specified days
Specified dose on specified days
City of Hope Comprehensive Cancer Center
Duarte, California, United States
University of Colorado
Aurora, Colorado, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Tennesse Oncology - NASH - SCRI - PPDS
Chattanooga, Tennessee, United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Sir Mortimer B Davis Jewish General Hospital-3755 Cote Sainte-Catherine
Montreal, Quebec, Canada
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Clinica Universidad de Navarra-Madrid
Madrid, Spain
...and 1 more locations
Number of Participants iwth Dose Limiting Toxicity (DLTs)
Time frame: Up to approximately 5 years
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 5 years
Maximum Serum Concentration (Cmax) of RO7759065
Time frame: Up to approximately 5 years
Objective Response Rate (ORR)
Time frame: Up to Approximately 5 Years
Duration of Response (DOR)
Time frame: Up to approximately 5 years
Progression Free Survival (PFS)
Time frame: Up to approximately 5 years
Percentage of Participants With Anti-Drug Antibodies (ADAs) to RO7759065
Time frame: Up to approximately 5 years
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