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

NCT ID: NCT06939036

Last Updated: 2025-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Small Cell Lung Cancer Extensive Stage Merkel Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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225Ac-SSO110 + SoC

Group Type EXPERIMENTAL

225Ac-SSO110 + SoC

Intervention Type DRUG

Dose Level -2-7

Atezolizumab

Intervention Type DRUG

Extensive Stage Small Cell Lung Cancer Checkpoint Inhibitor (SoC)

Durvalumab

Intervention Type DRUG

Extensive Stage Small Cell Lung Cancer Checkpoint Inhibitor (SoC)

Avelumab

Intervention Type DRUG

Merkel Cell Carcinoma Checkpoint Inhibitor (SoC)

Pembrolizumab

Intervention Type DRUG

Merkel Cell Carcinoma Checkpoint Inhibitor (SoC)

Retifanlimab

Intervention Type DRUG

Merkel Cell Carcinoma Checkpoint Inhibitor (SoC)

Interventions

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225Ac-SSO110 + SoC

Dose Level -2-7

Intervention Type DRUG

Atezolizumab

Extensive Stage Small Cell Lung Cancer Checkpoint Inhibitor (SoC)

Intervention Type DRUG

Durvalumab

Extensive Stage Small Cell Lung Cancer Checkpoint Inhibitor (SoC)

Intervention Type DRUG

Avelumab

Merkel Cell Carcinoma Checkpoint Inhibitor (SoC)

Intervention Type DRUG

Pembrolizumab

Merkel Cell Carcinoma Checkpoint Inhibitor (SoC)

Intervention Type DRUG

Retifanlimab

Merkel Cell Carcinoma Checkpoint Inhibitor (SoC)

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ariceum Therapeutics GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Biogenix Molecular

Miami, Florida, United States

Site Status RECRUITING

University of Louisville Health-Brown Cancer Center

Louisville, Kentucky, United States

Site Status RECRUITING

United Theranostics

Glen Burnie, Maryland, United States

Site Status RECRUITING

John Theurer Cancer Center at Hackensack UMC

Hackensack, New Jersey, United States

Site Status RECRUITING

UPMC

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

Site Status RECRUITING

GenesisCare

Alexandria, , Australia

Site Status RECRUITING

Countries

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United States Australia

Central Contacts

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Ariceum Therapeutics Clinical Trials

Role: CONTACT

+49 30 94 89 3360

Facility Contacts

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Milka Vina

Role: primary

+1 786 791 1799

Neal Dunlap, MD

Role: primary

Amanda Huggins

Role: primary

667-HOPENOW

Amber Hazledine

Role: backup

Oncology Clinical Research Referral Office

Role: primary

551-996-1777

Sam Demko

Role: primary

Carrie Friedman, RN, BSN, OCN

Role: primary

703-636-1473

Dr. Joe Cardaci

Role: primary

Other Identifiers

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2024-515041-42-00

Identifier Type: CTIS

Identifier Source: secondary_id

SAX101

Identifier Type: -

Identifier Source: org_study_id

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