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

(SANTANA-225 Trial)

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

Trial Summary

What is the purpose of this trial?

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).

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.

What data supports the effectiveness of the drug 225Ac-SSO110 for treating small cell lung cancer?

While there is no direct data on 225Ac-SSO110, research shows that small cell lung cancer is sensitive to chemotherapy and targeted therapies, with some new agents showing promise in clinical trials. This suggests that innovative treatments like 225Ac-SSO110 could potentially be effective. ^{1 2 3 4 5}

What makes the drug 225Ac-SSO110 unique for treating small cell lung cancer and Merkel cell carcinoma?

225Ac-SSO110 is unique because it likely targets somatostatin receptors, which are expressed in Merkel cell carcinoma, offering a novel approach compared to traditional chemotherapy that often has brief responses. ^{6 7 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Who Is Running the Clinical Trial?

Ariceum Therapeutics GmbH

Lead Sponsor

Trials

1

Recruited

20+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A phase-1b study of everolimus plus paclitaxel in patients with small-cell lung cancer. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Targeted therapies in small cell lung cancer: a review. [2021]

3. France pubmed.ncbi.nlm.nih.gov

[Medical treatment of small cell lung cancer: Can we leave the area of cisplatin-etoposide?] [2021]

4. France 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. [2023]

5. Denmark pubmed.ncbi.nlm.nih.gov

Treatment of small cell carcinoma of the lung. [2004]

6. United States pubmed.ncbi.nlm.nih.gov

Response of Merkel cell polyomavirus-positive merkel cell carcinoma xenografts to a survivin inhibitor. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Chemotherapy for Merkel cell carcinoma with carboplatin and etoposide. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Prognostic Factors in Merkel Cell Carcinoma: A Retrospective Single-Center Study in 90 Patients. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Milademetan is a highly potent MDM2 inhibitor in Merkel cell carcinoma. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Somatostatin receptor expression in Merkel cell carcinoma as target for molecular imaging. [2021]