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

Servier

Status and phase

Terminated

Phase 1

Conditions

Advanced Solid Tumor

Treatments

Drug: 89Zr-S095012 tracer and S095012 will be administered via an IV infusion

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05638334

CL1-95012-002

2021-001764-20 (EudraCT Number)

Details and patient eligibility

About

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)

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.