RO7567132 and AtezolizumabRO7567132 and Atezolizumab
RO7567132 and Atezolizumab: RO7567132 will be administered either as monotherapy or in combination with atezolizumab at a dose and schedule as specified for the respective cohort.
RO7567132 and Atezolizumab: RO7567132 will be administered in combination with atezolizumab at a dose and schedule as specified for the respective cohort.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Male or female participants aged ≥18 years
* Body weight \> 40 kilograms (kg)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 and Life expectancy of at least 12 weeks
* Participants with advanced and/or metastatic solid tumors
* Availability and willingness to provide a mandatory archival tumor specimen or (if not available) a fresh baseline biopsy
* Negative serum pregnancy test
* Participants must have adequate cardiovascular, hematological, liver and renal function.
Exclusion Criteria:
* Known central nervous system (CNS) tumors or metastases and leptomeningeal metastases
* Active second malignancy within 2 years prior to screening
* History or current clinically significant cardiovascular/cerebrovascular disease
* Active or history of autoimmune disease
* Serious, uncontrolled infection
* Known clinically significant liver disease
* Unresolved acute toxicity \> grade 1 from prior therapy
Primary outcome measure(s)
Percentage of Participants with Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) — Up to a maximum of 27 months
Percentage of Participants With Dose-limiting Toxicities (DLTs) — From baseline to 3 weeks on study
Trial sites (10)
Facility
City
Region
Status
Kinghorn Cancer Centre
Darlinghurst
New South Wales
Austin Health
Heidelberg
Victoria
UZ Leuven Gasthuisberg
Leuven
Belgium
BC Cancer ? Vancouver
Vancouver
British Columbia
Princess Margaret Cancer Center
Toronto
Ontario
McGill University Health Center
Montreal
Quebec
Rigshospitalet
København Ø
Denmark
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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