For Healthcare Professionals

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

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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)
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. 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
  2. At least one measurable target lesion as per RECIST 1.1
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  4. Royal Marsden Prognosis score of 0 to 1 (score based on lactate dehydrogenase (LDH) value, albumin value and number of sites of metastasis)
  5. Adequate organ function as assessed by laboratory tests (especially adequate hepatic function)
  6. 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:

  1. Participants with no available archived material and no tumour lesions amenable to biopsy
  2. Participants with primary central nervous system malignancies, with Child-Pugh Class B8 or higher, or C liver cirrhosis
  3. Participants with active auto-immune disease or immune-related adverse event currently requiring systemic anti-inflammatory agent (more than 10mg/day prednisone or equivalent)
  4. Participants with a history of an opportunistic infection within a year before the administration of first study drug dose are excluded.
  5. 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.
  6. Participants with prior history of Grade ≥ 3 immune-related pneumonitis, colitis, hepatitis, or myocarditis
  7. Participants with a history of progressive multifocal leukoencephalopathy
  8. 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.
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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.
Phone iconCall +33155724366Email iconEmail Study Center

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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