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 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT06877533
Eligibility Criteria:
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Histologically or cytologically confirmed advanced or metastatic unresectable solid tumors for which standard approved treatment is not available or the participant is ineligible or did not tolerate the standard approved treatment.
* At least one tumor lesion measurable per RECIST v1.1
* Have an estimated minimum life expectancy of ≥ 12 weeks.
* Adequate organ/marrow and liver function
* Agree to use adequate highly effective method of contraception during the study is mandatory, if WOCBP or male
Exclusion Criteria:
* Prior systemic anticancer treatment including investigational agents within 3 weeks (or 5 half-lives, whichever is shorter) before the first dose of study treatment
* Major surgery planned or within 5 weeks before the first dose of study treatment, or minor surgical procedure (except tumor biopsy) within 7 days before the first dose of study treatment.
* Radiotherapy within 2 weeks before the first dose of study treatment.
* Evidence of severe active or chronic infections requiring systemic antibacterial, antiviral, or antifungal treatment, including tuberculosis infection
* Known seropositivity for or active infection with human immunodeficiency virus (HIV)
* Known seropositivity for hepatitis B virus (HBV), with evidence of active HBV infection
* Known seropositivity for hepatitis C virus (HCV), with evidence of active HCV infection
* Live or live-attenuated vaccine within 30 days before the first dose of study treatment.
* History or current evidence of uncontrolled or significant cardiovascular disease
* History or current evidence of significant autoimmune disease that required systemic
* treatment
* Diagnosis of immunodeficiency or any condition requiring systemic treatment with immunosuppressive medication
* Pregnant or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06877533
Study Brief:
Protocol Section:
NCT06877533