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

Last updated: June 20, 2025
Sponsor: Ariceum Therapeutics GmbH
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neuroendocrine Carcinoma

Carcinoma

Small Cell Lung Cancer

Treatment

Atezolizumab

Avelumab

Durvalumab

Clinical Study ID

NCT06939036
SAX101
2024-515041-42-00
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 atthe 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

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 enrolmentor scheduled to have major surgery during the study.

  • Inadequate organ or marrow function.

Study Design

Total Participants: 50
Treatment Group(s): 6
Primary Treatment: Atezolizumab
Phase: 1/2
Study Start date:
June 01, 2025
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Biogenix Molecular

    Miami, Florida 33165
    United States

    Active - Recruiting

  • University of Louisville Health-Brown Cancer Center

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • United Theranostics

    Glen Burnie, Maryland 21061
    United States

    Active - Recruiting

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