Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 )
NCT ID: NCT06939036
Last Updated: 2025-10-28
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/PHASE2
50 participants
INTERVENTIONAL
2025-07-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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225Ac-SSO110 + SoC
225Ac-SSO110 + SoC
Dose Level -2-7
Atezolizumab
Extensive Stage Small Cell Lung Cancer Checkpoint Inhibitor (SoC)
Durvalumab
Extensive Stage Small Cell Lung Cancer Checkpoint Inhibitor (SoC)
Avelumab
Merkel Cell Carcinoma Checkpoint Inhibitor (SoC)
Pembrolizumab
Merkel Cell Carcinoma Checkpoint Inhibitor (SoC)
Retifanlimab
Merkel Cell Carcinoma Checkpoint Inhibitor (SoC)
Interventions
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225Ac-SSO110 + SoC
Dose Level -2-7
Atezolizumab
Extensive Stage Small Cell Lung Cancer Checkpoint Inhibitor (SoC)
Durvalumab
Extensive Stage Small Cell Lung Cancer Checkpoint Inhibitor (SoC)
Avelumab
Merkel Cell Carcinoma Checkpoint Inhibitor (SoC)
Pembrolizumab
Merkel Cell Carcinoma Checkpoint Inhibitor (SoC)
Retifanlimab
Merkel Cell Carcinoma Checkpoint Inhibitor (SoC)
Eligibility Criteria
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Inclusion Criteria
* Participants with ES-SCLC (defined as Stage IV per NCCN guidelines Version 1.2024) or recurrent locally advanced or metastatic MCC (per NCCN guidelines Version 1.2024) documented by histology or cytology.
* Participants eligible to receive immune checkpoint inhibitor (CPI) monotherapy at the start of treatment with 225Ac-SSO110 or patients already on CPI monotherapy for 7 weeks.
* ECOG performance status of 0 or 1. Life expectancy of at least 6 months.
* Positive 68Ga-SSO120 scan (Investigator-assessed) during screening.
Exclusion Criteria
* Any previous systemic radioligand therapy or extensive radiotherapy.
* Participants receiving or planned to receive consolidative chest radiation.
* History of primary immunodeficiency, transplantation or CAR-T cell therapy.
* Major surgical procedure except diagnostic biopsy within 28 days prior to enrolment or scheduled to have major surgery during the study.
* Inadequate organ or marrow function.
18 Years
ALL
No
Sponsors
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Ariceum Therapeutics GmbH
INDUSTRY
Responsible Party
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Locations
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Biogenix Molecular
Miami, Florida, United States
University of Louisville Health-Brown Cancer Center
Louisville, Kentucky, United States
United Theranostics
Glen Burnie, Maryland, United States
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, United States
UPMC
Pittsburgh, Pennsylvania, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
GenesisCare
Alexandria, , Australia
Countries
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Central Contacts
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Facility Contacts
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Amber Hazledine
Role: backup
Other Identifiers
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2024-515041-42-00
Identifier Type: CTIS
Identifier Source: secondary_id
SAX101
Identifier Type: -
Identifier Source: org_study_id
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