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Recruiting
NCT05638334
Immuno-positron Emission Tomography Study of 89Zr-S095012 in Patients With Advanced Solid Tumours
Conditions: Advanced Solid Tumor
Sex: All
Ages: 18 Years – N/A
Phase: PHASE1
Enrollment: 33
Sponsor: Institut de Recherches Internationales Servier
Location: Netherlands
Summary
The purpose of this study is to assess the whole-body biodistribution and tumour uptake of 89Zr-S095012 in participants with solid tumours treated by S095012 (PD-L1x4-1BB bispecific antibody)
Eligibility 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 toleratedAt least one measurable target lesion as per RECIST 1.1Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1Adequate organ function as assessed by laboratory tests (especially adequate hepatic function)Exclusion Criteria:Participants with no available archived material and no tumour lesions amenable to biopsyParticipants with primary central nervous system malignancies, with Child-Pugh Class B8 or higher, or C liver cirrhosisParticipants with active auto-immune disease or immune-related adverse event currently requiring systemic anti-inflammatory agentParticipants with prior history of Grade ≥ 3 immune-related pneumonitis, colitis, hepatitis, and myocarditis
Source: ClinicalTrials.gov (NCT05638334). StuddyBuddy aggregates publicly available trial information.