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

Ariceum Therapeutics GmbH

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Small Cell Lung Cancer Extensive Stage; Merkel Cell Carcinoma

Treatments: Drug: Durvalumab; Drug: Pembrolizumab; Drug: Atezolizumab; Drug: Retifanlimab; Drug: Avelumab; Drug: 225Ac-SSO110 + SoC

Study type: Interventional

Funder types: Industry

Identifiers

NCT06939036

2024-515041-42-00 (EU Trial (CTIS) Number)

SAX101

Details and patient eligibility

About

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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

225Ac-SSO110 + SoC

Experimental group

Treatment:

Drug: 225Ac-SSO110 + SoC

Drug: Avelumab

Drug: Retifanlimab

Drug: Atezolizumab

Drug: Pembrolizumab

Drug: Durvalumab