Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 ) (NCT06939036) | Clinical Trial Compass
TerminatedPhase 1/2
Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 )
Stopped: Study terminated due to strategic business decisions.
United States, Australia2 participantsStarted 2025-07-01
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1: Safety, tolerability, RP2D of 225Ac-SSO110 in combination with SoC
Timeframe: 42 days
2
Part 2: Safety, tolerability, and preliminary anti-tumor activity of 225Ac-SSO110 in combination with SoC at RP2D
Timeframe: 42 days
3
Part 1 & 2: Safety and tolerability of 68Ga-SSO120