Study of 225Ac-SS0110 in Subjects with ES-SCLC or MCC ( SANTANA-225 )
Research type
Research Study
Full 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) (The SANTANA-225 Study)
IRAS ID
1010832
Contact name
Shelby Hartzell
Contact email
Sponsor organisation
Ariceum Therapeutics GmbH
Clinicaltrials.gov Identifier
Research summary
Extensive stage small cell lung cancer (ES-SCLC) and recurrent locally advanced or metastatic Merkel cell carcinoma (MCC) are two types of cancer that have limited therapeutic options. Some cancer cells have a specific receptor on the surface of the cell that is called somatostatin receptor 2 (SSTR2). This receptor can bind small molecules that carry small amounts of radioactivity. This can be used to see and to fight the cancer. This study will test two experimental drugs named 225Ac-SSO110 and 68Ga-SSO120. 68Ga-SSO120 binds to the SSTR2 receptor and will help the investigators see if this receptor is present on cancer cells. 225Ac-SSO110 also binds to this receptor and delivers radiation to the tumour, that can damage the cancer cells. The main purpose of the study is to check how safe the study drugs are. The study is divided into 2 parts: Part 1 will test the optimal dose of 225Ac-SSO110 for cancer treatment, Part 2 will test this optimal dose of 225Ac-SSO110 in a larger number of participants in both type of cancers to confirm the safety and to test its antitumour activity.Throughout the study, participants will continue to receive the best therapy for this type of cancer.This is an open-label study, which means that participants, physicians and study teams, and the Sponsor will know the study drugs they receive.Participants initially go through a screening period to find out if they are eligible to receive 225Ac-SSO110.If eligible, they will go to the treatment phase and into the follow-up period to look for any possible long-term side effects related to the study treatment.The study will include adults with at least 18 years of age, with either ES-SCLC or MCC cancer, that has grown outside the body part where it started (advanced) or has spread to other parts of the body(metastatic).Both study medications will be given by intravenous injection in the arm.68Ga-SSO120 will be given once during screening.225Ac-SSO110 will be given several times during the study.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
25/LO/0774
Date of REC Opinion
3 Dec 2025
REC opinion
Further Information Favourable Opinion