Trials / Recruiting
RecruitingNCT07107490
A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 122 (estimated)
- Sponsor
- Chugai Pharmaceutical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | ALPS12 | ALPS12 as an IV infusion |
| DRUG | obinutuzumab | Obinutuzumab as an IV infusion |
Timeline
- Start date
- 2025-10-08
- Primary completion
- 2028-09-30
- Completion
- 2028-09-30
- First posted
- 2025-08-06
- Last updated
- 2026-02-06
Locations
6 sites across 3 countries: Hong Kong, Japan, Taiwan
Source: ClinicalTrials.gov record NCT07107490. Inclusion in this directory is not an endorsement.