A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER
NCT07107490 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 122
Last updated 2026-02-06
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.
Conditions
Interventions
- DRUG
-
ALPS12
ALPS12 as an IV infusion
- DRUG
-
Obinutuzumab as an IV infusion
Sponsors & Collaborators
-
Chugai Pharmaceutical
lead INDUSTRY
Principal Investigators
-
Sponsor Chugai Pharmaceutical Co.Ltd · [email protected]
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-08
- Primary Completion
- 2028-09-30
- Completion
- 2028-09-30
Countries
- Hong Kong
- Japan
- Taiwan
Study Locations
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