177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors

Inclusion criteria

• ✓. Willing and able to provide informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.
• ✓. Adult participants ≥ 18 years of age.
• ✓. Participants with a documented history of histopathologically confirmed relapsed/refractory locally advanced, inoperable or metastatic NSCLC, SCLC, TNBC, cutaneous melanoma, HNSCC, endometrial cancer or any cancer that is known to be MMR deficient or MSI high with documented disease progression during or after their most recent line of anticancer therapy. Participants must be refractory to or have refused standard of care therapy (including PD-1/PD-L1 inhibitors) or have refused or have no standard of care therapy available that is likely to provide clinical benefit.
• ✓. Participants with PD-L1 positive NSCLC, SCLC, TNBC, cutaneous melanoma, HNSCC, endometrial cancer or any cancer that is known to be MMR deficient or MSI high:
• ✓. Must have at least 1 measurable target lesion according to RECIST version 1.1.
• ✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• ✓. Participants must have a life expectancy of ≥ 4 months in the opinion of the Investigator.
• ✓. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test 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 sterilisation should be considered for further investigation with luteinising hormone (LH) and follicle stimulating hormone (FSH) levels to confirm serological post-menopausal status.