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A Study to Evaluate Safety, Pharmacokinetics and Anti-Tumor Activity of RO7300490, as Single Agent or in Combination With Atezolizumab in Participants With Advanced Solid Tumors
A Study to Evaluate Safety, Pharmacokinetics and Anti-Tumor Activity of RO7300490, as Single Agent or in Combination With Atezolizumab in Participants With Advanced Solid Tumors
CompletedPhase 1
Sponsor: Hoffmann-La Roche
Conditions: Solid Tumors
Interventions: RO7300490, Atezolizumab
Countries: Denmark, France, South Korea, Spain, United Kingdom
A study to evaluate the safety, pharmacokinetics and anti-tumor activity of RO7300490 as a single agent or in combination with atezolizumab. The study will consist of 3 parts: \[Part 1\] Dose-Escalation of RO7300490 as a single agent; \[Part 2\] Dose-Escalation of RO7300490 in combination with atezolizumab and \[Part 3\] Dose-Expansion of RO7300490 in combination with atezolizumab in selected cancer types.
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * Life expectancy of \>= 12 weeks. * Histologically confirmed diagnosis of locally advanced and/or metastatic solid tumors that are not amenable to standard therapy. * Radiologically measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Agreement to provide protocol-specific biopsy material. * Adverse Events (AEs) from prior anti-cancer therapy resolved to Grade =\<1. * Adequate performance status and cardiovascular, hematological, liver, renal and coagulation function. * For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating eggs. * For male participants: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm. Exclusion Criteria: * Known central nervous system (CNS) primary tumors or metastases, including leptomeningeal metastases, unless protocol-specific conditions are met. * Active second invasive malignancy within two years prior to screening. * Significant cardiovascular/cerebrovascular disease within 6 months prior to study treatment start. * Any other diseases, metabolic dysfunction, physical examination finding or clinical laboratory finding that gives reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug. * Prior allogeneic bone marrow transplantation or prior solid organ transplantation. * Active or history of autoimmune disease. * Known hypersensitivity to any of the components of RO7300490 formulation or to components of atezolizumab formulation. * Pregnancy, lactation or breastfeeding. * Dementia or altered mental status that would prohibit informed consent. * Major surgery or significant traumatic injury within 28 days prior to the first study drug administration (excluding biopsies) or anticipation of the need for major surgery during study treatment. * Treatment with radiotherapy, chemotherapy, hormonal therapy, targeted therapy, immunotherapy or investigational drug concurrent or within 28 days or 5 half-lives of the drug (whichever is shorter) before the first study drug administration.
Locations (11)
- København Ø, Denmark
- Villejuif, France
- Seoul, South Korea
- Seoul, South Korea
- Pamplona, Navarre, Spain
- Barcelona, Spain
- Madrid, Spain
- Madrid, Spain
- Edinburgh, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom