Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 )
Megadott ok: Study terminated due to strategic business decisions.
Key facts
- Where
- Fairfax, Glen Burnie, Hackensack, Louisville, Miami és Pittsburgh, Egyesült ÁllamokSee the 6 sites
- Phase
- 1/2. fázis
Where in Egyesült Államok
- Virginia Cancer Specialists PCFairfax, Egyesült ÁllamokNo longer taking part
- United TheranosticsGlen Burnie, Egyesült ÁllamokNo longer taking part
- John Theurer Cancer Center At Hackensack UMCHackensack, Egyesült ÁllamokNo longer taking part
- University of Louisville Health Brown Cancer CenterLouisville, Egyesült ÁllamokNo longer taking part
- Biogenix MolecularMiami, Egyesült ÁllamokNo longer taking part
- UPMCPittsburgh, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Ariceum Therapeutics GmbH
- Trial code
- NCT06939036EU 2024-515041-42-00
- Record updated
- 2026. február 5.
- Original description
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).Read full original descriptionShow less
A Multicentre, Open-label, Phase I/II Study Investigating the Safety, Tolerability, and Preliminary Efficacy of 225Ac-SSO110 in Participants With Extensive Stage Small Cell Lung Cancer (ES-SCLC) or Merkel Cell Carcinoma (MCC) Receiving Standard of Care (SoC)
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).
Inclusion: 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.
Exclusion: Any previous systemic radioligand therapy or extensive radiotherapy; Participants receiving or planned to receive consolidative chest radiation; Major surgical procedure except diagnostic biopsy within 28 days prior to enrolment or scheduled to have major surgery during the study; History of primary immunodeficiency, transplantation or CAR-T cell therapy; Participants with unstable spinal cord compression; Inadequate organ or marrow function.