Tests ALPS12 in adults with extensive-stage small cell lung cancer
Tests the new drug ALPS12 in adults with advanced small cell lung cancer.
Key facts
- Who runs it
- Chugai Pharmaceutical
- Where
- Changhua, TaiwanSee the siteAlso in 2 other countries, 5 sites
- Trial code
- Registry title
- A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 122 people, planned
- Started
- 8 Oct 2025
- Expected to end
- 30 Sept 2028
- Type of study
- Interventional, 2 groups
- Treatments tested
- ALPS12
- obinutuzumab
- Record updated
- 6 February 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with extensive stage small cell lung cancer whose cancer came back after at least one earlier systemic treatment.
- Age
- Older than 18 years.
- Sex
- All sexes can join.
- Disease stage
- Small cell lung cancer in the extensive stage, confirmed under the microscope. The disease can be measured on scans (RECIST v.1.1).
- Earlier treatment
- The cancer must have come back after at least one earlier systemic therapy. Earlier treatment with anti-CD137 antibody drugs, anti-CD3 antibody drugs or DLL3-targeted therapies is not allowed. Any anticancer therapy within 21 days before the first dose is not allowed. A live attenuated vaccine within 4 weeks before the first dose is not allowed.
- Biomarker or test result
- A stored tumour sample or a fresh tumour sample must be available. ECOG performance status must be 0 or 1. Blood counts and organ function must be adequate.
Main reasons for not taking part
- Pregnant or breastfeeding, or planning to become pregnant
- Significant autoimmune disease
- Positive HIV antibody test, or active hepatitis B or hepatitis C
- Brain or spinal cord (CNS) cancer, symptomatic CNS metastases, or leptomeningeal disease
- Serious immune-related side effects from earlier anti-PD-L1/PD-1 or anti-CTLA-4 drugs
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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)
- 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
- Pregnant or breastfeeding, or intending to become pregnant or breastfeeding during the study
Where in Taiwan
Also in 2 other countries, 5 sites
- Show Chwan Memorial HospitalChanghua, TaiwanTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Dose escalation partTreatment being tested
Patients will receive ALPS12 as a single agent following pretreatment of obinutuzumab to determine the MTD by evaluating DLTs in patients with extensive stage small cell lung cancer.
Treatment: ALPS12 and obinutuzumab
- Expansion partTreatment being tested
Patients will receive ALPS12 as a single agent following pretreatment of obinutuzumab to evaluate the antitumor effect.
Treatment: ALPS12 and obinutuzumab
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Tests ALPS12 in adults with extensive-stage small cell lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 6 February 2026