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 @ 4:05 PM
Ignite Modification Date:
2025-12-24 @ 4:05 PM
NCT ID:
NCT06008366
Eligibility Criteria:
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Life expectancy of at least 3 months as assessed by the Investigator.
* Histologically or cytologically confirmed locally advanced or metastatic solid tumor, progressive after last treatment received and who progressed on or after standard therapies or intolerant to approved therapies or who lack of effient standard therapies.
* An archival tumor tissue sample(formalin-fixed paraffin-embedded (FFPE) tumor tissue block or at least 5 unstained slides) or a fresh tissue sample should be provided. If the tissue sample cannot be provided during dose escalation, enrollment into the study is allowed after discussion with the Investigator
* Measurable or evaluable disease by RECIST v1.1.
* Have adequate hematopoietic, renal and hepatic functions.
* Men or women willing to use adequate contraceptive measures throughout the study.
Exclusion Criteria:
* Have other prior malignancies within 3 years before the first administration.
* Known central nervous system metastatic disease or carcinomatous meningitis except for treated and stable brain metastases.
* Have significant, uncontrolled, or active cardiovascular disease.
* Known history of COPD, or intestinal lung disease, or other respiratory diseases requring inpatient treatments within 4 weeks prior to first administration.
* Have adverse events due to prior antitumor therapy not resolved to grade 1 or lower by NCI CTCAE V5.0.
* Have active infections requiring treatment within 14 weeks; have infection of HIV, active infection of HCV and HBV.
* Prior treatment with an antibody drug conjugate (ADC) that consists of an topoisomerase I inhibitor.
* Prior treatment with B7-H3 targeted agents.
* Have received chemotherapy, immunotherapy, curative radiation within 3 weeks prior to the first administration or targeted molecular within 2 weeks prior to first administration. have received Chinese patent medicine or Chinese herbs of anti-tumor indications within 1 weeks prior to the first administration.
* Have received any systemic immunosuppressants within 2 weeks prior to the first administration except for topical corticosteroids.
* Have received any other investigational drugs or medical device within 4 weeks prior to the first administration.
* History of drug abuse including narcotic and psychiatric drugs within 12 months prior to screening.
* Pregnant, or nursing females.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06008366
Study Brief:
Protocol Section:
NCT06008366