NCT06939036

Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 )

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)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Ariceum Therapeutics GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 receptor 2 expressing (SSTR2+) extensive-stage small cell lung cancer (ES-SCLC) and recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

Conditions

• Small Cell Lung Cancer Extensive Stage
• Merkel Cell Carcinoma

Interventions

Type	Name	Description
DRUG	225Ac-SSO110 + SoC	Dose Level -2-7
DRUG	Atezolizumab	Extensive Stage Small Cell Lung Cancer Checkpoint Inhibitor (SoC)
DRUG	Durvalumab	Extensive Stage Small Cell Lung Cancer Checkpoint Inhibitor (SoC)
DRUG	Avelumab	Merkel Cell Carcinoma Checkpoint Inhibitor (SoC)
DRUG	Pembrolizumab	Merkel Cell Carcinoma Checkpoint Inhibitor (SoC)
DRUG	Retifanlimab	Merkel Cell Carcinoma Checkpoint Inhibitor (SoC)

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-04-22
• Last updated: 2026-02-05

Locations

7 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study