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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT07052760
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years
2. Histopathologically confirmed solid tumors in one of the following cohorts:
1. Cohort 1 (n=15): Histologically confirmed prostate cancer, with castration resistant disease per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria.
2. Cohort 2 (n=15): Histologically confirmed high grade neuroendocrine tumor, with a Ki-67 over 20.
3. Cohort 3 (n=15): Agnostic to tumor type.
3. Metastatic disease present on conventional imaging defined as having Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable disease or multiple bone metastases.
4. Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria:
1. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
2. Has known hypersensitivity to Chinese hamster ovary cell products.
3. Has a history of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
4. Known pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07052760
Study Brief:
Protocol Section:
NCT07052760