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A Study to Evaluate the Safety and Tolerability of RO7296682 in Combination With Atezolizumab in Participants With Advanced Solid Tumors.
A Study to Evaluate the Safety and Tolerability of RO7296682 in Combination With Atezolizumab in Participants With Advanced Solid Tumors.
TerminatedPhase 1
Sponsor: Hoffmann-La Roche
Conditions: Solid Tumors
Interventions: RO7296682, Atezolizumab
Countries: United States, Australia, Belgium, Canada, Denmark, Spain
This study will evaluate the safety, tolerability and preliminary anti-tumor activity of RO7296682 in combination with Atezolizumab in participants with advanced solid tumors.
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: \- Diagnosis of advanced and/or metastatic solid tumors who have progressed on a standard therapy, are intolerant to standard of care (SoC), and/or and non-amenable to SoC. Participants whose tumors have known sensitizing mutations must have experienced disease progression (during or after treatment) or intolerance to treatment with a respective targeted therapy. * Measurable disease according to RECIST v1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Able to provide the most recent archival tumor tissue samples. * Adequate cardiovascular, haematological, liver and renal function. * Participants on therapeutic anticoagulation must be on a stable anticoagulant regimen. * Women of Childbearing Potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods. * Men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods and refrain from donating sperm. Exclusion Criteria: * Pregnancy, lactation, or breastfeeding. * Known hypersensitivity to any of the components of RO7296682 and atezolizumab, including but not limited to hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies. * History or clinical evidence of central nervous system (CNS) primary tumors or metastases. * Participants with another invasive malignancy in the last two years. * Participants with known active or uncontrolled infection. * Positive HIV test at screening. * Positive for Hepatitis B and C. * Vaccination with live vaccines within 28 days prior to C1D1. * Major surgical procedure or significant traumatic injury within 28 days prior to first RO7296682 and atezolizumab infusion. * Participants with wound healing complications. * Dementia or altered mental status that would prohibit informed consent. * History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or DRESS (drug rash with eosinophilia and systemic symptoms). * Active or history of autoimmune disease or immune deficiency. * Prior treatment with CPIs (e.g. anti-CTLA4, anti-PD1, anti-PDL1), immunomodulatory monoclonal antibodies (mAbs) and/or mAb-derived therapies (approved or investigational) is approved. * Treatment with standard radiotherapy, any chemotherapeutic agent, targeted therapy or treatment with any other investigational drug (defined as treatment for which there is currently no regulatory authority-approved indication) within 28 days or 5 half-lives of the drug (whichever is shorter), prior to the first RO7296882 administration on C1D1. * Radiotherapy within the last 4 weeks before start of study drug treatment, with the exception of limited palliative radiotherapy (for which no wash out period is required).
Locations (10)
- Houston, Texas, United States
- Melbourne, Victoria, Australia
- Brussels, Belgium
- Vancouver, British Columbia, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- København Ø, Denmark
- Pamplona, Navarre, Spain
- Barcelona, Spain
- Valencia, Spain