A Dose-escalation Study of RO7567132 as Single Agent and in Combination With Atezolizumab in Participants With Advanced Solid Tumors
- Registration Number
- NCT06537310
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part I: RO7567132 Dose Escalation With or Without Atezolizumab RO7567132 and Atezolizumab - Part II: RO7567132 Backfill With Atezolizumab RO7567132 and Atezolizumab -
- Primary Outcome Measures
Name Time Method Percentage of Participants With Dose-limiting Toxicities (DLTs) From baseline to 3 weeks on study 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
- Secondary Outcome Measures
Name Time Method 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 Minimum Concentration (Cmin) Up to maximum of 24 Months 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 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
Trial Locations
- Locations (11)
Kinghorn Cancer Centre
🇦🇺Darlinghurst, New South Wales, Australia
Austin Health
🇦🇺Heidelberg, Victoria, Australia
UZ Leuven Gasthuisberg
🇧🇪Leuven, Belgium
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, Navarra, Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
🇪🇸Barcelona, Spain
Clinica Universidad de Navarra Madrid
🇪🇸Madrid, Spain
Fundacion Jimenez Diaz
🇪🇸Madrid, Spain