Immuno-positron Emission Tomography Study of 89Zr-S095012 in Patients With Advanced Solid Tumours
About the study
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)
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Advanced Solid Tumor
Age
18+
Phase
PHASE1
Participants Needed
33
Est. Completion Date
Sep 30, 2025
Treatment Type
INTERVENTIONAL
Sponsor
Servier
ClinicalTrials.gov NCT Identifier
NCT05638334
Study Number
CL1-95012-002
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