A Phase Ia/Ib, Open-Label, Multicenter study to evaluate the Safety, Pharmacokinetics, and activity of Ro7759065 as a single agent and in combination with ATEZOLIZUMAB in Patients with locally advanced or metastatic solid tumors
Primary:
To evaluate the safety of RO7759065 when administered as a single agent (Phase Ia) or in combination with atezolizumab (Phase Ib)
Secondary:
To characterize the pharmacokinetics of RO7759065 when administered as a single agent (Phase Ia) or in combination with atezolizumab (Phase Ib)
To make a preliminary assessment of the activity of RO7759065 when administered as a single agent (Phase Ia) or in combination with atezolizumab (Phase Ib)
To evaluate the immune response to RO7759065 when administered as a single agent (Phase Ia) or in combination with atezolizumab (Phase Ib)
To identify a recommended dose and regimen for RO7759065 for subsequent studies
Ro7759065
Chemotherapy single agent systemic
- Rutgers University
Inclusion Criteria: - Life expectancy at least 12 weeks - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Adequate hematologic and end-organ function - Measurable disease according to Response Evaluation criteria in Solid Tumors (RECIST) Version 1.1 - Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy - Availability of representative tumor specimens required for patients in select cohorts. Exclusion Criteria: - Women who are pregnant or breastfeeding - Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment - Active hepatitis B or C or tuberculosis - Positive test for human immunodeficiency virus (HIV) infection - Acute or chronic active Epstein-Barr virus (EBV) infection at screening - Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first RO7759065 infusion - Primary, untreated, or active central nervous system (CNS) metastases - Active or history of autoimmune disease or immune deficiency - Prior allogeneic stem cell or organ transplantation - Any history of a Grade 3 immune-mediated adverse event attributed to prior cancer immunotherapy that resulted in permanent discontinuation of that agent - Any history of a Grade 4 immune-mediated adverse event attributed to prior cancer immunotherapy.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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