Clinical Research Directory
Browse clinical research sites, groups, and studies.
A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER
Sponsor: Chugai Pharmaceutical
Summary
This study is a phase I, open-label, multicenter trial designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of ALPS12 in patients with extensive-stage small cell lung cancer. The study consists of two parts: a dose-escalation part and an expansion part.
Official title: AN OPEN-LABEL, MULTICENTER PHASE I STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND PRELIMINARY ANTI-TUMOR ACTIVITY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
122
Start Date
2025-10-08
Completion Date
2028-09-30
Last Updated
2026-02-06
Healthy Volunteers
No
Conditions
Interventions
ALPS12
ALPS12 as an IV infusion
obinutuzumab
Obinutuzumab as an IV infusion
Locations (6)
Queen Mary Hospital
Hong Kong, Hong Kong
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Ehime University Hospital
Tōon, Ehime, Japan
Kindai University Hospital
Sakai, Osaka, Japan
Niigata Cancer Center Hospital
Niigata, Japan
Show Chwan Memorial Hospital
Changhua, Taiwan