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Study of AUBE00 in Patients With Solid Tumors
Sponsor: Chugai Pharmaceutical
Summary
This is a first-in-human, Phase I, open-label, multicenter, multinational study, designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and anti-tumor activity of AUBE00 in patients with locally advanced or metastatic solid tumors.The total number of patients in this study will be approximately 90 to 130.
Official title: A Phase I Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of AUBE00 in Patients With Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2025-06-05
Completion Date
2029-12-31
Last Updated
2026-02-25
Healthy Volunteers
No
Conditions
Interventions
AUBE00
AUBE00 as an oral administration
Cetuximab
Cetuximab as an IV infusion
Locations (4)
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan