NCT07107490RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 122 (estimated)
- First submitted
- 30 Jul 2025
- Start date
- 8 Oct 2025
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- Chugai Pharmaceutical
- Diseases
- Lung cancer
- NCT number
- NCT07107490
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 122
- From 8 Oct 2025 to the primary completion date, 30 Sept 2028
- 6 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with anti-CD137 antibody drugs, anti-CD3 antibody drugs, and/or DLL3-targeted therapies
- Patients who have received any investigational or approved anticancer therapy, including hormone therapy and/or radiotherapy, within 21 days prior to the first administration of the investigational drug.
- Patients who received a live attenuated vaccine within 4 weeks prior to the first administration of the investigational drug
Other illness
- History or complication of clinically significant autoimmune disease
- a positive HIV antibody test at screening
- Active hepatitis B or hepatitis C
- History or clinical evidence of primary central nervous system (CNS) malignancy, symptomatic CNS metastases, CNS metastases requiring any anti tumor treatment, or leptomeningeal disease
- Current or past CNS diseases (e.g., stroke, epilepsy, CNS vasculitis, neurodegenerative diseases)
Lab values
- History of Grade 4 immune-related adverse events caused by prior anti-PD-L1/PD-1 antibody drugs or anti-CTLA-4 antibody drugs (excluding asymptomatic elevations in serum amylase/lipase)
- Patients who discontinued immunotherapy due to Grade 3 immune-related adverse events caused by prior anti-PD-L1/PD-1 antibody drugs or anti-CTLA-4 antibody drugs (excluding asymptomatic elevations in serum amylase/lipase), and/or patients who experienced Grade 3 immune-related adverse events caused by immunotherapy within 6 months prior to the first administration of the investigational drug
Other
- Pregnant or breastfeeding, or intending to become pregnant or breastfeeding during the study
Who the study is looking for
- Aged \>18 years at time of informed consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
- Histologically documented extensive stage small cell lung cancer
- Disease recurrence documented after at least one prior systemic therapy.
- Confirmed availability of representative archival tumor specimens or fresh tumor specimen.
- Measurable disease per RECIST v.1.1.
- Adequate hematologic and end organ function
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa | Japan | Recruiting |
| Niigata Cancer Center Hospital Coordinator of this site? Confirm its status | Niigata | Japan | Recruiting |
| Kindai University Hospital Coordinator of this site? Confirm its status | Sakai | Japan | Recruiting |
| Ehime University Hospital Coordinator of this site? Confirm its status | Tōon | Japan | Recruiting |
| Show Chwan Memorial Hospital Coordinator of this site? Confirm its status | Changhua | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.