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A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-Care Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors
About
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of RO7496353 when administered in combination with a checkpoint inhibitor (CPI) with or without standard-of-care (SOC) chemotherapy in participants with locally advanced or metastatic solid tumors such as non-small cell lung cancer (NSCLC), gastric cancer (GC) and pancreatic ductal adenocarcinoma (PDAC). The study will be conducted in 2 stages: an initial safety run-in stage and an expansion stage.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy at least 3 months
- Adequate hematologic and end organ function
- Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
- Measurable disease according to RECIST v1.1 on computed tomography (CT) or magnetic resonance imaging (MRI) images within 28 days prior to enrollment
- Availability of representative tumor specimens in formalin-fixed, paraffin-embedded (FFPE) blocks or at least 15 unstained slides
Exclusion Criteria:
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 9 months after the final dose of oxaliplatin and within 6 months after the final dose of all other study treatment
- Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
- History of leptomeningeal disease
- Uncontrolled tumor-related pain
- Positive test for human immunodeficiency virus (HIV) infection
- Positive hepatitis B surface antigen (HbsAg) test, and/or positive total hepatitis B core antibody (HbcAb) test at screening
- Positive hepatitis C virus (HCV) antibody test at screening
- Known allergy or hypersensitivity to any component of the RO7496353 formulation or any of the study drugs or their excipients
Other protocol-defined inclusion/exclusion criteria may apply.
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Study Stats
Protocol No.
23-001279
Category
Lung Cancer
Pancreatic Cancer
Sarcoma
Stomach Cancer
Principal Investigator
Contact
Location
- UCLA Santa Monica