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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT06779851
Eligibility Criteria:
Inclusion Criteria:
* Male or female aged ≥18 years at the time of signing informed consent form
* Measurable disease per RECIST 1.1
* Histologically- or cytologically-diagnosed, locally advanced unresectable or metastatic solid tumor. Progressed or recurred after previously having received approved standard of care agents that are approved and available in their local geography.
* ECOG Performance status of 0 or 1
* Life expectancy of at least 3 months
* Adequate organ and marrow function
* Contraception during study participation, as applicable
Exclusion Criteria:
* Has received systemic small molecule therapy or radiation therapy within 28 days prior to the first dose.
* Treatment with biologic agents including anti-PD-1 or PD-L1 antibodies for less than 6 weeks or 5 half-lives, whichever is shorter, prior to first dose.
* Received any investigational agent less than 28 days or 5 half-lives, whichever is shorter, prior to the first dose.
* Treatment with another IL-18 therapy.
* Received systemic immunosuppressive agents greater than the equivalent of prednisone 10mg daily within 14 days of the study, though inhaled, intranasal, topical or intra-articular corticosteroids are allowed.
* Certain clinically significant intercurrent disease.
* Primary immune deficiency.
* Active untreated brain or spine metastasis or leptomeningeal metastases.
* Known HIV seroposivitiy, although patients treated for HIV with no detectable viral load for at least 1 month while on a stable regimen of agents are permitted.
* Active hepatitis A or acute or chroming hepatitis B or C infection.
* Received a live virus vaccine within 30 days of enrollment or a COVD vaccine within 14 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06779851
Study Brief:
Protocol Section:
NCT06779851