A multicentre, open-label, Phase I study investigating the safety, tolerability, and efficacy of 177Lu-SSO110 with 68Ga-SSO120 companion imaging in participants with extensive stage small cell lung cancer (ES-SCLC) who are on maintenance treatment with immune checkpoint inhibition (The LuSato1 Study).

ACTRN 12623000185662

Brief Summary

This study aims to assess the safety and tolerability of two new drugs in patients with extensive stage small cell lung cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (ES SCLC). The first drug (68Ga-SSO120/68Ga-Satoreotide Trizoxetan) is used as a tumoura tissue mass that forms from groups of unhealthy cells imagingtests that create detailed images of areas inside the body agent for patients who have tumours with specific receptors, while the second drug (177Lu-SSO110) targets and damages cancer cellsthe basic structural and functional unit of all living things with these specific receptors.

Intervention/Treatment

• Drug: 68Ga-SSO120 (68Ga-Satoreotide Trizoxetan).
• Drug: 177Lu-SSO110.

Inclusion Criteria

1. Aged at least 18 years (inclusive at the time of informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment.).
2. Must be able and willing to provide written informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.
3. Confirmation of SCLC by histology or cytology. Confirmation of extensive stage SCLC by imaging.
4. Adequate organ and marrow function within 7 days prior to the first dosethe amount of medication taken of 177LuSSO110 as defined below:
   • absolute neutrophil count >1,000/µL;
   • plateletssmall disc-shaped blood cells that clump together to form clots to stop bleeding of >=100,000/µL;
   • total bilirubin >=1.5 × upper limit of normal (ULN) or >=3.0 × ULN for participants with hereditary benignnot cancerous, can grow but will not spread to other body parts hyperbilirubinemia;
   • AST (aspartate aminotransferase or serum glutamic oxaloacetic transaminase, SGOT) and ALT (alanine aminotransferase or serum glutamic pyruvic transaminase, SGPT) <=3 × ULN (or <=5 × ULN if liver metastases are present);
   • serum creatinine <=1.5 × ULN;
   • estimated glomerular filtration rate >=45 mL/min/1.73 m2;
   • serum albumin >=30 g/L.
5. Life expectancy of >18 weeks at confirmation of eligibility, in the opinion of the Investigator.
6. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin test within 72 hours before the first dose of study drug and must not be breastfeeding. WOCBP are defined as those who are not surgically sterile or post-menopausal. Female participants will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. Female participants <50 years old who meet the criteria for post-menopausal status without previous surgical sterilization should be considered for further investigation with luteinising hormonea chemical substance produced by glands in the endocrine system that regulates various functions in the body and follicle stimulating hormone levels to confirm serological post-menopausal status.
7. WOCBP must agree to use a highly effective method of contraception during the study and for 90 days after the last dose of study drug.
8. Male participants who are able to father a child must agree to avoid impregnating a partner and to adhere to a highly effective method of contraception during the study and for 90 days after the last dose of study drug. All male participants must agree to not donate sperm during the study and for 90 days after the last dose of study drug.
9. Positive 68Ga-SSO120 scan at screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening is mandatory (positive being at least one lesion concordant with a known lesion based on CT or FDGPET/CT with uptake visually assessed
   as greater than the liver on 68Ga-SSO120 scan). In case there are no visible lesions on CT (complete response) or a 68Ga-SSO120 scan cannot be performed due to technical reasons, a positive test for SST2 from archival tissuea group of cells that work together to perform a function or cytology (e.g., Fine Needle Aspiration (FNA)) (positive being a H-score >50) is required.
10. To receive the first dose of 177Lu-SSO110, participants must have completed induction therapy with cisplatin/carboplatin, etoposide and ICI, and be eligible for maintenance therapy with an ICI.
11. Participants with brain metastases are eligible to participate if:
    • they are clinically and radiologically stable disease (no evidence of progression by imaging; same imaging modality [magnetic resonance imaging or CT scan]) must be used for each assessment) for at least 28 days prior to the first dose of study drug;
    • any neurologic symptoms returned to baseline;
    • no longer on steroids.

Note: Participants with a history of leptomeningeal disease may not participate even if stable clinically.