225Ac-SSO110 for Small Cell Lung Cancer and Merkel Cell Carcinoma

(SANTANA-225 Trial)

Recruiting at 6 trial locations

Overseen By Ariceum Therapeutics Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Ariceum Therapeutics GmbH

Must be taking: Immune checkpoint inhibitors

Must not be taking: Systemic radioligand therapy

Disqualifiers: Unstable spinal cord compression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called 225Ac-SSO110, combined with standard care, for certain types of cancer. It targets small cell lung cancer and Merkel cell carcinoma, particularly when the cancer has spread extensively or returned after treatment. The main goal is to determine if this treatment is safe and effective in reducing cancer activity. Candidates for this trial should have a positive test for a specific receptor (a type of cell marker) and be receiving or eligible for certain immune therapies. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants can be on immune checkpoint inhibitor therapy, so you might be able to continue some treatments. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that 225Ac-SSO110 is likely to be safe for humans?

Research has shown that 225Ac-SSO110 holds promise as a treatment for certain cancers, such as small cell lung cancer and Merkel cell carcinoma. Early results suggest it represents a new type of therapy targeting specific cancer cells. In these early testing stages, the primary goal is to assess its safety and patient tolerance.

Detailed safety information from the studies is not yet available. However, the FDA's decision to allow this treatment to continue in trials indicates a positive outlook. This approval suggests that early tests have demonstrated sufficient potential safety for further study. While detailed safety data is still forthcoming, progression in the trial phases implies it is considered safe enough for testing in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about 225Ac-SSO110 because it introduces a new approach to treating small cell lung cancer and Merkel cell carcinoma through the use of targeted alpha therapy. Unlike standard chemotherapy options that broadly attack rapidly dividing cells, 225Ac-SSO110 specifically targets cancer cells with a radioactive particle, actinium-225, delivering potent energy directly to the tumor while minimizing damage to surrounding healthy tissue. This precise mechanism has the potential to improve effectiveness and reduce side effects, offering hope for better outcomes in these aggressive cancers.

What evidence suggests that 225Ac-SSO110 might be an effective treatment for small cell lung cancer and Merkel cell carcinoma?

Research has shown that 225Ac-SSO110, the investigational treatment studied in this trial, could be a promising option for small cell lung cancer (SCLC) and Merkel cell carcinoma (MCC). This therapy, a type of radioligand, uses tiny radioactive particles to target and destroy cancer cells with a specific marker called somatostatin receptor 2 (SSTR2). Early studies suggest it might effectively reduce tumors in these cancers. The FDA has acknowledged its potential by granting it orphan drug status, a designation for treatments expected to offer significant benefits. Although more research is needed, initial data indicate that 225Ac-SSO110 could offer hope for patients with these challenging cancers. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for people with extensive-stage small cell lung cancer (ES-SCLC) or advanced/metastatic Merkel cell carcinoma (MCC) that express somatostatin receptor 2. Participants should meet specific health criteria not detailed here.

Inclusion Criteria

Positive 68Ga-SSO120 scan (Investigator-assessed) during screening

My cancer is either stage IV small cell lung cancer or advanced Merkel cell carcinoma.

Signed Informed Consent Form and willing to comply with all study procedures

Exclusion Criteria

I have unstable spinal cord compression.

History of primary immunodeficiency, transplantation or CAR-T cell therapy

I am scheduled for or receiving chest radiation after initial treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 225Ac-SSO110 in combination with standard of care therapy to assess safety, tolerability, and preliminary antitumor activity

6 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 225Ac-SSO110

Trial Overview The study tests the combination of a new drug, 225Ac-SSO110, with standard cancer treatments against other approved immunotherapies like Avelumab and Pembrolizumab to see which is safer and works better.

How Is the Trial Designed?

Group I: 225Ac-SSO110 + SoC Experimental Treatment 6 Interventions

Who Is Running the Clinical Trial?

Ariceum Therapeutics GmbH

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

Small cell lung cancer (SCLC) is highly aggressive and often relapses after initial treatment, leading to poor survival rates, highlighting the need for new therapeutic strategies.

Recent research has identified several molecular targets for SCLC, and new agents are being developed and tested in clinical trials to improve treatment outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted therapies in small cell lung cancer: a review. Abidin, AZ., Garassino, MC., Califano, R., et al.[2021]

In a small study of three patients with Merkel cell carcinoma treated with carboplatin and etoposide, two patients achieved partial remission, indicating that this chemotherapy combination may be effective for this rare skin cancer.

Despite initial responses, the remissions were short-lived, and two patients did not respond to subsequent chemotherapy; however, one patient achieved a complete response with a different second-line treatment combined with radiotherapy, suggesting that while Merkel cell carcinoma can respond to treatment, long-term efficacy may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemotherapy for Merkel cell carcinoma with carboplatin and etoposide. Pectasides, D., Moutzourides, G., Dimitriadis, M., et al.[2019]

Small cell lung cancer (SCLC) is a challenging type of cancer, making up 14% of lung cancers, with limited progress in treatment over the past 30 years, highlighting the need for new therapeutic strategies.

The review discusses potential pathways for improving SCLC outcomes, including targeting DNA damage repair mechanisms and developing immuno-oncological agents, suggesting a shift towards precision medicine in treating this cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Medical treatment of small cell lung cancer: Can we leave the area of cisplatin-etoposide?] Pujol, JL., Roch, B., Pujol, CN., et al.[2021]

Lurbinectedin treatment for small cell lung cancer (SCLC) showed improved median overall survival (OS) of 9.3 months compared to 6.1 months for the historical standard of care, based on a synthetic control arm analysis of 174 patients in Alberta, Canada.

The effectiveness of lurbinectedin was particularly notable in patients with a chemotherapy-free interval of 90 days or more, where the hazard ratio for improved survival was 0.49, indicating a significant survival benefit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Lurbinectedin for the Treatment of Relapsed Small Cell Lung Cancer in the Post-Platinum Setting: A Real-World Canadian Synthetic Control Arm Analysis. Boyne, DJ., Dawe, DE., Shakir, H., et al.[2023]

Small cell carcinoma of the lung is highly responsive to chemotherapy, with combination treatments achieving partial or complete remissions in 80-90% of untreated patients, significantly extending median survival by three to five times.

Despite strong initial responses to treatment, long-term outcomes are poor, with only a 5-10% disease-free survival rate at two years, highlighting the need for improved treatment strategies and supportive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of small cell carcinoma of the lung. Sörenson, S.[2004]

Citations

1. ariceum-therapeutics.com ariceum-therapeutics.com/ariceum-therapeutics-data-at-the-2025-european-association-of-nuclear-medicine-annual-congress-further-supports-the-advancement-of-225ac-sso110-for-extensive-stage-small-cell-lung-cancer-and-merkel-ce/

Ariceum Therapeutics Data at the 2025 European ... These results reinforce the therapeutic potential of 225Ac-SSO110 as a next-generation alpha-emitting radioligand therapy for SSTR2-positive ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06939036

Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC ... This study aims to determine safety, tolerability, recommended phase 2 dose (RP2D), and preliminary antitumor activity of 225Ac-SSO110 with standard of care ( ...

3. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_1/575/756089/Abstract-575-225Ac-SSO110-as-next-generation-SSTR2

Abstract 575: 225Ac-SSO110 as next-generation SSTR2 ... SSO110 (DOTA-JR11) is a somatostatin receptor 2 (SSTR2) antagonist currently under clinical development in small cell lung cancer (SCLC).

4. targetedonc.com targetedonc.com/view/fda-clears-225ac-sso110-for-phase-1-2-sclc-and-merkel-cell-carcinoma-trial

FDA Clears 225Ac-SSO110 for Phase 1/2 SCLC and ... The FDA has approved the investigational new drug application of 225Ac-SSO110, allowing for the start of a phase 1/2 trial in patients with extensive-stage ...

5. cancernetwork.com cancernetwork.com/view/orphan-drug-designation-granted-to-225ac-sso110-for-sclc

Orphan Drug Designation Granted to 225Ac-SSO110 for ... FDA clears Ariceum Therapeutics' 225Ac-satoreotide phase I/II clinical study in patients with small cell lung cancer or merkel cell carcinoma.

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/598555

Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC ... This study aims to determine safety, tolerability, recommended phase 2 dose (RP2D), and preliminary antitumor activity of 225Ac-SSO110 with ...

7. sg.finance.yahoo.com sg.finance.yahoo.com/news/ariceum-therapeutics-doses-first-patient-070000279.html

Ariceum Therapeutics Doses First Patient in SANTANA- ... 225Ac-SSO110 has received U.S. FDA Orphan Drug Designation. Initial safety data from SANTANA-225 in ES-SCLC and MCC expected in 2026.