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:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-24 @ 4:03 PM
NCT ID:
NCT05429866
Eligibility Criteria:
Inclusion Criteria:
* 1\) Age ≥ 18 years old
* 2\) ECOG performance status ≤ 1
* 3\) Must have histologically or cytologically confirmed solid tumour, eligible for treatment with ICI as standard-of-care alone or in combination with another ICI (cohort 1), ICI with chemotherapy (cohort 2), or ICI with targeted therapy (cohort 3) with no restrictions on number of prior systemic therapies
* 4\) All prior anti-cancer treatment-related toxicities (except alopecia) must be ≤ Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 at the time of enrolment
* 5\) Serum pregnancy test (for subjects of childbearing potential) negative within 15 days prior to study medications administration.
* 6\) Women of childbearing potential must agree to use one highly effective method of contraception prior study entry, during the course of the study and at least 7 months after the last administration of study treatments.
* 7\) Men with childbearing potential partner must agree to use condom during the course of this study and for at least 6 months after the last administration of the study treatments.
* 8\) Completion of all necessary screening procedures within 14 days prior to enrolment.
* 9\) Signed Informed Consent form (ICF) obtained prior to any study related procedure.
Exclusion Criteria:
* Subjects meeting one of the following criteria are not eligible for this study:
1. Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.
2. Participation in another clinical trial.
3. Pregnant and/or lactating women.
4. Subjects already receiving ICI.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05429866
Study Brief:
Protocol Section:
NCT05429866