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

Launched by ARICEUM THERAPEUTICS GMBH · Apr 15, 2025

Keywords

ClinConnect Summary

The SANTANA-225 trial is studying a new treatment called 225Ac-SS0110 for patients with advanced small cell lung cancer (ES-SCLC) or Merkel cell carcinoma (MCC), a type of skin cancer. The goal of this study is to see how safe this treatment is, how well it works alongside standard therapies, and to find the best dose for future studies. If you or a loved one have been diagnosed with either of these cancers and meet specific criteria, you may be eligible to participate in this trial.

To qualify, participants should have advanced-stage cancer confirmed by medical tests and be able to receive certain other treatments at the same time. They should also be in relatively good health, with a life expectancy of at least six months. The trial is currently recruiting participants, and those who join can expect to receive careful monitoring and support throughout the study. It's important to know that there are some health conditions and treatments that could exclude someone from participating, so a thorough screening process is in place.

Gender

ALL

Eligibility criteria

• 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.
• 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.