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A Phase I Study of ROSE12 Alone and in Combination With Other Anti-tumor Agents in Patients With Solid Tumors
Sponsor: Chugai Pharmaceutical
Summary
This is a Phase Ia/Ib open-label, dose-escalation study to evaluate the safety and pharmacokinetics of ROSE12 as a single agent and in combination with other anti-tumor agents in patients with locally advanced or metastatic solid tumors. The study will consist of three parts: a dose-escalation part, a biopsy part (the part to evaluate biomarkers), and an expansion part.
Official title: A Phase Ia/Ib Open-label, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of ROSE12 as a Single Agent and in Combination With Other Anti-tumor Agents in Patients With Locally Advanced or Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
219
Start Date
2023-05-24
Completion Date
2026-12-31
Last Updated
2025-03-06
Healthy Volunteers
No
Conditions
Interventions
ROSE12
ROSE12 as a IV infusion
Atezolizumab
Atezolizumab as a IV infusion
Locations (4)
MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology
Fairfax, Virginia, United States
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan