The purpose of this study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of RO7567132 as single agent and in combination with atezolizumab. The study will enroll adult participants with selected locally advanced and/or metastatic solid tumors for whom standard therapy does not exist, or has proven to be ineffective or intolerable.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
RO7567132 will be administered either as monotherapy or in combination with atezolizumab at a dose and schedule as specified for the respective cohort.
RO7567132 will be administered in combination with atezolizumab at a dose and schedule as specified for the respective cohort.
Kinghorn Cancer Centre
Darlinghurst, New South Wales, Australia
Austin Health
Heidelberg, Victoria, Australia
UZ Leuven Gasthuisberg
Leuven, Belgium
Percentage of Participants with Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Time frame: Up to a maximum of 27 months
Percentage of Participants With Dose-limiting Toxicities (DLTs)
Time frame: From baseline to 3 weeks on study
Maximum Concentration (Cmax) Derived for RO7567132
Time frame: Up to a maximum of 24 months
Time of Maximum Concentration (Tmax)
Time frame: Up to a maximum of 24 months
Minimum Concentration (Cmin)
Time frame: Up to maximum of 24 Months
Clearance (CL) or Apparent Clearance (CL/F)
Time frame: Up to a maximum of 24 months
Volume of Distribution at Steady State (Vss)
Time frame: Up to a maximum of 24 months
Area Under the Curve (AUC) for Various Time Intervals
Time frame: Up to a maximum of 24 months
Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7567132
Time frame: Up to 24 months
Objective Response Rate (ORR)
Time frame: Up to a maximum of 24 months
Disease Control Rate (DCR)
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BC Cancer ? Vancouver
Vancouver, British Columbia, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
McGill University Health Center
Montreal, Quebec, Canada
Rigshospitalet
København Ø, Denmark
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, Spain
Clinica Universidad de Navarra Madrid
Madrid, Spain
...and 1 more locations
Time frame: Up to a maximum of 24 months
Duration of Response (DoR)
Time frame: Up to a maximum of 24 months
Progression Free Survival (PFS)
Time frame: Up to a maximum of 24 months
Overall Survival (OS)
Time frame: Up to a maximum of 24 months