Cancer-Neoplasms
Conditions
Brief 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.
Interventions
DRUGRO7567132 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.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Concentration (Cmax) Derived for RO7567132 | Up to a maximum of 24 months |
| Time of Maximum Concentration (Tmax) | Up to a maximum of 24 months |
| Minimum Concentration (Cmin) | Up to maximum of 24 Months |
| Clearance (CL) or Apparent Clearance (CL/F) | Up to a maximum of 24 months |
| Volume of Distribution at Steady State (Vss) | Up to a maximum of 24 months |
| Area Under the Curve (AUC) for Various Time Intervals | Up to a maximum of 24 months |
| Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7567132 | Up to 24 months |
| Objective Response Rate (ORR) | Up to a maximum of 24 months |
| Disease Control Rate (DCR) | Up to a maximum of 24 months |
| Duration of Response (DoR) | Up to a maximum of 24 months |
| Progression Free Survival (PFS) | Up to a maximum of 24 months |
| Overall Survival (OS) | Up to a maximum of 24 months |
Countries
Australia, Belgium, Canada, Denmark, Spain
Contacts
STUDY_DIRECTORClinical trails
Hoffmann-La Roche
Outcome results
None listed