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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515041-42-00 | EU Trial (CTIS) Number |
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Study terminated due to strategic business decisions.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 225Ac-SSO110 + SoC | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 225Ac-SSO110 + SoC | Drug | Dose Level -2-7 |
| |
| Atezolizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Safety, tolerability, RP2D of 225Ac-SSO110 in combination with SoC | Identification of the DLT rate per dose level | 42 days |
| Part 2: Safety, tolerability, and preliminary anti-tumor activity of 225Ac-SSO110 in combination with SoC at RP2D | Rate of serious adverse events, adverse events, laboratory parameters, and other safety findings, Preliminary anti-tumor activity of 225Ac-SSO110 as assessed by progression free survival (PFS), disease control rate (DCR), best observed response (BOR), overall response rate (ORR), duration of response (DoR) | 42 days |
| Part 1 & 2: Safety and tolerability of 68Ga-SSO120 | Rate of serious adverse events, adverse events, laboratory parameters, and other safety findings | 7 days |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biogenix Molecular | Miami | Florida | 33165 | United States | ||
| University of Louisville Health-Brown Cancer Center |
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| Drug |
Extensive Stage Small Cell Lung Cancer Checkpoint Inhibitor (SoC) |
|
| Durvalumab | Drug | Extensive Stage Small Cell Lung Cancer Checkpoint Inhibitor (SoC) |
|
| Avelumab | Drug | Merkel Cell Carcinoma Checkpoint Inhibitor (SoC) |
|
| Pembrolizumab | Drug | Merkel Cell Carcinoma Checkpoint Inhibitor (SoC) |
|
| Retifanlimab | Drug | Merkel Cell Carcinoma Checkpoint Inhibitor (SoC) |
|
| Louisville |
| Kentucky |
| 40202 |
| United States |
| United Theranostics | Glen Burnie | Maryland | 21061 | United States |
| John Theurer Cancer Center at Hackensack UMC | Hackensack | New Jersey | 07601 | United States |
| UPMC | Pittsburgh | Pennsylvania | 15219 | United States |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | United States |
| GenesisCare | Alexandria | Australia |
| ID | Term |
|---|---|
| D015266 | Carcinoma, Merkel Cell |
| ID | Term |
|---|---|
| D027601 | Polyomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| C000613593 | durvalumab |
| C000609138 | avelumab |
| C582435 | pembrolizumab |
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