TERMINATED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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)

Quick Facts

Study Start:2025-07-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT06939036

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Signed Informed Consent Form and willing to comply with all study procedures.
  2. * 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.
  3. * 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.
  4. * ECOG performance status of 0 or 1. Life expectancy of at least 6 months.
  5. * Positive 68Ga-SSO120 scan (Investigator-assessed) during screening.
  1. * Participants with unstable spinal cord compression.
  2. * Any previous systemic radioligand therapy or extensive radiotherapy.
  3. * Participants receiving or planned to receive consolidative chest radiation.
  4. * History of primary immunodeficiency, transplantation or CAR-T cell therapy.
  5. * Major surgical procedure except diagnostic biopsy within 28 days prior to enrolment or scheduled to have major surgery during the study.
  6. * Inadequate organ or marrow function.

Contacts and Locations

Study Locations (Sites)

Biogenix Molecular
Miami, Florida, 33165
United States
University of Louisville Health-Brown Cancer Center
Louisville, Kentucky, 40202
United States
United Theranostics
Glen Burnie, Maryland, 21061
United States
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, 07601
United States
UPMC
Pittsburgh, Pennsylvania, 15219
United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Ariceum Therapeutics GmbH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2025-07-01
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • actinium
  • 225Ac
  • actinium-225
  • SSO110
  • SSO120
  • gallium
  • 68Ga
  • gallium-68
  • radiopharmaceutical
  • MCC
  • Merkel Cell carinoma
  • ES-SCLC
  • Extensive Stage Small Cell Lung Cancer
  • radioligand
  • somatostatin receptor 2
  • JR11
  • sstr2-antagonist

Additional Relevant MeSH Terms

  • Small Cell Lung Cancer Extensive Stage
  • Merkel Cell Carcinoma