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

Phase 1

Recruiting

• Conditions: Small Cell Lung Cancer Extensive Stage; Merkel Cell Carcinoma
• Interventions: Drug: 225Ac-SSO110 + SoC; Drug: Atezolizumab; Drug: Durvalumab; Drug: Avelumab; Drug: Pembrolizumab; Drug: Retifanlimab

• Registration Number: NCT06939036
• Lead Sponsor: Ariceum Therapeutics GmbH

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-15
• Study First Submitted QC: 2025-04-15
• Study First Posted: 2025-04-22
• Study Start: 2025-06-01
• Last Update Submitted: 2025-06-20
• Last Update Posted: 2025-06-25
• Primary Completion: 2026-08
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
225Ac-SSO110 + SoC	225Ac-SSO110 + SoC	-
225Ac-SSO110 + SoC	Atezolizumab	-
225Ac-SSO110 + SoC	Durvalumab	-
225Ac-SSO110 + SoC	Avelumab	-
225Ac-SSO110 + SoC	Pembrolizumab	-
225Ac-SSO110 + SoC	Retifanlimab	-

Primary Outcome Measures

Name	Time	Method
Part 1 & 2: Safety and tolerability of 68Ga-SSO120	7 days	Rate of serious adverse events, adverse events, laboratory parameters, and other safety findings
Part 1: Safety, tolerability, RP2D of 225Ac-SSO110 in combination with SoC	42 days	Identification of the DLT rate per dose level
Part 2: Safety, tolerability, and preliminary anti-tumor activity of 225Ac-SSO110 in combination with SoC at RP2D	42 days	Rate of serious adverse events, adverse events, laboratory parameters, and other safety findings, Preliminary anti-tumor activity of 225Ac-SSO110 as assessed by progression free survival (PFS), disease control rate (DCR), best observed response (BOR), overall response rate (ORR), duration of response (DoR)

Trial Locations

Locations (3)

University of Louisville Health-Brown Cancer Center; 🇺🇸 Louisville, Kentucky, United States

United Theranostics; 🇺🇸 Glen Burnie, Maryland, United States

Biogenix Molecular; 🇺🇸 Miami, Florida, United States