Phase 1 ALPS12 treatment for extensive-stage small cell lung cancer
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
Run by Chugai Pharmaceutical · NCT07107490 · Data updated 2026-11-12
This trial tests a new drug called ALPS12, given alone or with obinutuzumab, in adults with extensive-stage small cell lung cancer that has returned after prior therapy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 122 (estimated) |
| Sponsor | Chugai Pharmaceutical Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 6 sites (Hong Kong and 5 other locations) |
| Status | Recruiting |
| Started | October 8, 2025 |
| Main results expected | September 30, 2028 |
| Study ends | September 30, 2028 |
| Registry record updated | February 6, 2026 |
| Trial ID | NCT07107490 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (over 18) with histologically confirmed extensive-stage small cell lung cancer, ECOG 0–1, measurable disease, adequate organ function, available tumor tissue, and disease recurrence after at least one prior systemic therapy are the intended participants.
✕Probably not a fit
Patients who are pregnant or breastfeeding, have active hepatitis B/C or HIV, significant autoimmune disease, prior anti-CD137/anti-CD3/DLL3-targeted therapies, or recent anticancer therapy within 21 days are excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a phase I, open-label, multicenter trial with a dose-escalation phase followed by an expansion phase to characterize safety and early signs of activity. Participants will receive ALPS12, with some cohorts also receiving obinutuzumab, and will be closely monitored for adverse events, pharmacokinetics, and immune responses. Measurable disease per RECIST v1.1 and available tumor tissue are required to permit evaluation of antitumor effects and biomarker studies. The trial enrolls adults with ECOG performance status 0–1 who have progressed after at least one prior systemic therapy.
Why it matters
Potential benefit: If successful, ALPS12 could offer a new treatment option that shrinks tumors or prolongs survival for patients with relapsed extensive-stage small cell lung cancer.
How similar studies have gone: ALPS12 appears to be a novel agent and while other targeted and immune approaches in small cell lung cancer have shown mixed or limited gains, the field has not yet delivered a broadly successful targeted therapy for relapsed disease.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Pregnant or breastfeeding, or intending to become pregnant or breastfeeding during the study * History or complication of clinically significant autoimmune disease * a positive HIV antibody test at screening * Active hepatitis B or hepatitis C * 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. * 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 * Patients who received a live attenuated vaccine within 4 weeks prior to the first administration of the investigational drug * 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)
Where it's running
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Queen Mary Hospital
Hong Kong, Hong Kong Recruiting -
National Cancer Center Hospital East
Kashiwa, Chiba, Japan Recruiting -
Ehime University Hospital
Tōon, Ehime, Japan Recruiting -
Kindai University Hospital
Sakai, Osaka, Japan Recruiting -
Niigata Cancer Center Hospital
Niigata, Japan Recruiting -
Show Chwan Memorial Hospital
Changhua, Taiwan Recruiting
Study contacts
- Study coordinator: Clinical trials information
- Email: clinical-trials@chugai-pharm.co.jp
- Phone: only use Email
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.