A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER
NCT ID: NCT07107490
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
122 participants
INTERVENTIONAL
2025-10-08
2028-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose escalation part
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.
ALPS12
ALPS12 as an IV infusion
obinutuzumab
Obinutuzumab as an IV infusion
Expansion part
Patients will receive ALPS12 as a single agent following pretreatment of obinutuzumab to evaluate the antitumor effect.
ALPS12
ALPS12 as an IV infusion
obinutuzumab
Obinutuzumab as an IV infusion
Interventions
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ALPS12
ALPS12 as an IV infusion
obinutuzumab
Obinutuzumab as an IV infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Chugai Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Ehime University Hospital
Tōon, Ehime, Japan
Kindai University Hospital
Sakai, Osaka, Japan
Niigata Cancer Center Hospital
Niigata, , Japan
Countries
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Central Contacts
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Other Identifiers
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ALP102CT
Identifier Type: -
Identifier Source: org_study_id
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