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

A

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

Trial contacts and locations

4

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Central trial contact

Ariceum Therapeutics Clinical Trials

Data sourced from clinicaltrials.gov

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