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

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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06939036
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Ariceum Therapeutics GmbH
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Small Cell Lung Cancer Extensive Stage, Merkel Cell Carcinoma

Arms & Interventions

Arms

Experimental: 225Ac-SSO110 + SoC

Interventions

Drug: - 225Ac-SSO110 + SoC

Dose Level -2-7

Drug: - Atezolizumab

Extensive Stage Small Cell Lung Cancer Checkpoint Inhibitor (SoC)

Drug: - Durvalumab

Extensive Stage Small Cell Lung Cancer Checkpoint Inhibitor (SoC)

Drug: - Avelumab

Merkel Cell Carcinoma Checkpoint Inhibitor (SoC)

Drug: - Pembrolizumab

Merkel Cell Carcinoma Checkpoint Inhibitor (SoC)

Drug: - Retifanlimab

Merkel Cell Carcinoma Checkpoint Inhibitor (SoC)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Biogenix Molecular, Miami, Florida

Status

Recruiting

Address

Biogenix Molecular

Miami, Florida, 33165

Site Contact

Milka Vina

[email protected]

+1 786 791 1799