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 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT05363605
Eligibility Criteria:
Key Inclusion Criteria:
* Signed ICF prior to initiation of any study-specific procedures
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Histologically and/or cytologically documented diagnosis of locally advanced, inoperable, or metastatic solid tumours
* Refractory to all standard treatments, or for whom standard treatment is not available, or tolerable, or is contraindicated, or the participant refuses standard therapy
* Measurable disease per RECIST v. 1.1
* Available tumour tissue (archival or fresh biopsy)
* Adequate bone marrow, heart, liver, and kidney function
Key Exclusion Criteria:
* Prior systemic radiopharmaceutical therapy within six months prior to the first dose of \[111In\]-FPI-1967
* Prior radiation therapy (RT) to bone marrow \> 20 Gy
* RT within 30 days prior to the first dose of \[111In\]-FPI-1967
* Prior anti-cancer treatment (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, or investigational agents) within a certain amount of time prior to administration of the first dose of \[111In\]-FPI-1967
* Concurrent serious co-morbidities that could limit participants' full participation and compliance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05363605
Study Brief:
Protocol Section:
NCT05363605