Clinical trial · Interventional
Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 )
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study terminated due to strategic business decisions.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Merkel Cell Carcinoma | Merkel Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Small Cell Lung Cancer Extensive Stage | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 225Ac-SSO110 + SoC | Drug | — | UNRESOLVED |
| Atezolizumab | Drug | Atezolizumab | ALIAS |
| Avelumab | Drug | Avelumab | ALIAS |
| Durvalumab | Drug | Durvalumab | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| Retifanlimab | Drug | Retifanlimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 225Ac-SSO110 + SoC
- interventionNames
- Drug: 225Ac-SSO110 + SoC
- Drug: Atezolizumab
- Drug: Durvalumab
- Drug: Avelumab
- Drug: Pembrolizumab
- Drug: Retifanlimab
Primary outcomes (3)
- measure
- Part 1: Safety, tolerability, RP2D of 225Ac-SSO110 in combination with SoC
- timeFrame
- 42 days
- description
- Identification of the DLT rate per dose level
- measure
- Part 2: Safety, tolerability, and preliminary anti-tumor activity of 225Ac-SSO110 in combination with SoC at RP2D
- timeFrame
- 42 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available