Immuno-positron Emission Tomography Study of 89Zr-S095012 in Patients With Advanced Solid Tumours
Launched by INSTITUT DE RECHERCHES INTERNATIONALES SERVIER · Dec 5, 2022
Trial Information
Current as of January 21, 2025
Terminated
Keywords
ClinConnect Summary
No description provided
Gender
ALL
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 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.
About Institut De Recherches Internationales Servier
Institut de Recherches Internationales Servier is a leading independent international pharmaceutical company based in France, dedicated to advancing medical research and developing innovative therapeutic solutions. With a strong focus on areas such as cardiology, diabetes, oncology, and neuropsychiatry, Servier is committed to improving patient outcomes through rigorous clinical trials and collaboration with healthcare professionals worldwide. The organization emphasizes a patient-centric approach and invests significantly in research and development, striving to address unmet medical needs and enhance the quality of life for patients globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Amsterdam, , Netherlands
Groningen, , Netherlands
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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