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

Sponsor: Ariceum Therapeutics GmbH

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06939036

Patient View

This clinical trial evaluates the safety, tolerability, and preliminary antitumor activity of 225Ac-SSO110 combined with standard of care (SoC) therapies in patients with SSTR2+ ES-SCLC or MCC. Eligible participants must have a positive 68Ga-SSO120 scan and an ECOG status of 0 or 1. Interventions include 225Ac-SSO110 with SoC drugs like Atezolizumab, Durvalumab, Avelumab, Pembrolizumab, and Retifanlimab.

Patient Parameters

Program Overview

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).

Eligibility Criteria

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.

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