Esophageal Cancer Clinical Trial
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Summary
This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of RO7502175 when administered as a single agent and in combination with atezolizumab in adult participants with locally advanced or metastatic solid tumors, including non-small-cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.
Eligibility Criteria
Inclusion Criteria:
Life expectancy at least 12 weeks
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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
Tumor Specimen availability
Exclusion Criteria:
Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study treatment
Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, 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 RO7502175 infusion
Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
Active or history of autoimmune disease
Prior allogeneic stem cell or organ transplantation
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There are 33 Locations for this study
San Francisco California, 94305, United States
Aurora Colorado, 80045, United States
Sarasota Florida, 34232, United States
Atlanta Georgia, 30322, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48202, United States
Saint Louis Missouri, 63110, United States
New Brunswick New Jersey, 08901, United States
Germantown Tennessee, 38138, United States
Nashville Tennessee, 37203, United States
San Antonio Texas, 98229, United States
Darlinghurst New South Wales, 2010, Australia
Clayton Victoria, 3168, Australia
Nedlands Western Australia, 6009, Australia
Edegem , 2650, Belgium
Liège , 4000, Belgium
Wilrijk , 2610, Belgium
Vancouver British Columbia, V5Z 4, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 1, Canada
Montreal Quebec, H3T 1, Canada
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 120-7, Korea, Republic of
Amsterdam , 1066 , Netherlands
Groningen , 9713 , Netherlands
L?Hospitalet De Llobregat Barcelona, 08908, Spain
Barcelona , 08035, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Malaga , 29010, Spain
Valencia , 46010, Spain
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