A PHASE Ib STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF RO7496353 IN COMBINATION WITH A CHECKPOINT INHIBITOR WITH OR WITHOUT STANDARD-OF-CARE CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED OR METAS

JRCT ID: jRCT2031230222

Registered date:13/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: solid tumor
• Date of first enrollment: 02/10/2023
• Target sample size: 120
• Countries of recruitment: US,Japan,Brazil,Japan,Spain,Japan,Italy,Japan,Turkey,Japan,Serbia,Japan,S Korea,Japan,New Zealand,Japan,Australia,Japan
• Study type: Interventional

Intervention(s)

RO7496353: IV on Day 1 of each cycle
Atezolizumab: IV on Day 1 of each cycle
Capecitabine: PO twice daily on Days 1-14
Tegafur Gimeracil Oteracil Potassium: PO twice daily on Days 1-14
Nivolumab:IV on Day 1 of each cycle

Outcome(s)

Primary Outcome

safety
AEs will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).

Secondary Outcome

efficacy
Confirmed Objective Response Rate (ORR) as Determined by the Investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Eunpi Cho
• Secondary ID(s): NCT05867121