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

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de Recherches Internationales Servier
• Collaborator: ADIR, a Servier Group company

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

• Adequate 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 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

• Participants with prior history of Grade ≥ 3 immune-related pneumonitis, colitis, hepatitis, and myocarditis