Immuno-positron Emission Tomography Study of 89Zr-S095012 in Patients With Advanced Solid Tumours

An Open Label, Multicentre, Positron Emission Tomography (PET) Imaging Study Using Zirconium-89 to Investigate the Biodistribution and Tumour Uptake of a PD-L1x4-1BB Bispecific Antibody (S095012) in Patients With Advanced Solid Tumours

The purpose of this study is to assess the whole-body biodistribution and tumour uptake of 89Zr-S095012 in participants with solid tumours treated with S095012 (PD-L1x4-1BB bispecific antibody)

Inclusion Criteria:

• Histologically confirmed diagnosis of unresectable, locally advanced or metastatic solid tumour, for which standard treatment options are not available, no longer effective, or not tolerated
• At least one measurable target lesion as per RECIST 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Royal Marsden Prognosis score of 0 to 1 (score based on lactate dehydrogenase (LDH) value, albumin value and number of sites of metastasis)
• Adequate organ function as assessed by laboratory tests (especially adequate hepatic function)
• Negative test results for cytomegalovirus (CMV), Epstein-Barr virus (EBV), Hepatitis B virus (HBV), and Hepatitis C virus (HCV) infection, according to local standards.

Exclusion Criteria:

• Participants with no available archived material and no tumour lesions amenable to biopsy
• Participants with primary central nervous system malignancies, with Child-Pugh Class B8 or higher, or C liver cirrhosis
• Participants with active auto-immune disease or immune-related adverse event currently requiring systemic anti-inflammatory agent (more than 10mg/day prednisone or equivalent)
• Participants with a history of an opportunistic infection within a year before the administration of first study drug dose are excluded.
• Participants who received either systemic corticosteroids (> 10 mg per day of prednisone or equivalent) or other immunosuppressive medication during the 2 months prior to the first dose of the study drug are excluded.
• Participants with prior history of Grade ≥ 3 immune-related pneumonitis, colitis, hepatitis, or myocarditis
• Participants with a history of progressive multifocal leukoencephalopathy
• Participants must not have a history of active tuberculosis requiring treatment within 3 years prior to the start of treatment or a suspicion of latent tuberculosis by the investigator.