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

Last updated: April 15, 2025
Sponsor: Ariceum Therapeutics GmbH
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neuroendocrine Carcinoma

Small Cell Lung Cancer

Carcinoma

Treatment

Atezolizumab

Retifanlimab

Avelumab

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 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

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

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

Connect with a study center

  • Biogenix Molecular

    Miami, Florida 33165
    United States

    Active - Recruiting

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