Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT05638334
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05638334
Study Brief:
Protocol Section:
NCT05638334