Clinical trial · Interventional
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
NCT05638334CI-TRIAL-00103413terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 89Zr-S095012 tracer and S095012 will be administered via an IV infusion | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 89Zr-S095012 tracer with S095012
- interventionNames
- Drug: 89Zr-S095012 tracer and S095012 will be administered via an IV infusion
Primary outcomes (15)
- measure
- Change in PET/CT scan images
- timeFrame
- Within 14 days following the tracer injection and baseline (before the first treatment administration (during the dose range finding period))
- description
- Visual analysis of target lesions
- measure
- Change in PET/CT scan images
- timeFrame
- Within 14 days following the tracer injection and baseline (before the first treatment administration)
- description
- Visual analysis of target lesions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.