Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 )
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 receptor 2 expressing (SSTR2+) extensive-stage small cell lung cancer (ES-SCLC) and recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
Checked against the public recordLast updated Feb 5, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Ariceum Therapeutics GmbH
- Interventions being studied
- Drug: 225Ac-SSO110 + SoC; Drug: Atezolizumab; Drug: Durvalumab; Drug: Avelumab; Drug: Pembrolizumab; Drug: Retifanlimab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Key Inclusion Criteria: * 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 Criteria: * 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Biogenix MolecularMiami, Florida
- University of Louisville Health-Brown Cancer CenterLouisville, Kentucky
- United TheranosticsGlen Burnie, Maryland
- John Theurer Cancer Center at Hackensack UMCHackensack, New Jersey
- UPMCPittsburgh, Pennsylvania
- Virginia Cancer Specialists, PCFairfax, Virginia
- GenesisCareAlexandria
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 5, 2026. Always confirm current availability with the study team.