Phase 1 ALPS12 treatment for 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
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 |
| Enrollment | 122 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chugai Pharmaceutical Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 6 sites (Hong Kong and 5 other locations) |
| Trial ID | NCT07107490 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hong Kong and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.