A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER
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Sponsored by Chugai Pharmaceutical (industry) · 4519.T — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
122estimated
Sites
6
Countries
Hong Kong, Japan, Taiwan
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-10-08 | actual | When the study began enrolling |
| Primary completion | 2028-09-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-09-30 | estimated | The whole study's end, after follow-up |
| First posted | 2025-08-06 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Extensive Stage Small Cell Lung Cancer
Interventions
- Drug: ALPS12
- Drug: obinutuzumab
Primary outcomes
what the primary-completion date above is the date OFAll part : Adverse events of ALPS12[safety and tolerability]
measured From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)
Dose Escalation part : Dose-limiting toxicities (DLTs) and PK profile of ALPS12[safety and tolerability]
measured From Cycle 1 Day 1 to the administration of ALPS12 on Cycle 2 Day 1 (Cycle 1 is 21 days)
Dose Escalation part : Immunogenicity of ALPS12
measured From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)
Expansion part : Preliminary anti-tumor activity of ALPS12 when administered at selected dose(s) based on tumor assessment in patients with extensive stage SCLC
measured From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)
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