Status:
RECRUITING
Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 )
Lead Sponsor:
Ariceum Therapeutics GmbH
Conditions:
Small Cell Lung Cancer Extensive Stage
Merkel Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study aims to determine safety, tolerability, recommended phase 2 dose (RP2D), and preliminary antitumor activity of 225Ac-SSO110 with standard of care (SoC) therapy in patients with somatostatin...
Eligibility Criteria
Inclusion
- Key
- Signed Informed Consent Form and willing to comply with all study procedures.
- 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.
- Key
Exclusion
- Participants with unstable spinal cord compression.
- 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.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06939036
Start Date
July 1 2025
End Date
December 1 2026
Last Update
October 28 2025
Active Locations (7)
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1
Biogenix Molecular
Miami, Florida, United States, 33165
2
University of Louisville Health-Brown Cancer Center
Louisville, Kentucky, United States, 40202
3
United Theranostics
Glen Burnie, Maryland, United States, 21061
4
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, United States, 07601