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RECRUITING
NCT07107490
PHASE1

A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER

Sponsor: Chugai Pharmaceutical

View on ClinicalTrials.gov

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

Interventions

DRUG

ALPS12

ALPS12 as an IV infusion

DRUG

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