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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07466160
Eligibility Criteria:
Inclusion Criteria:
1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
2. Life expectancy of at least 3 months as assessed by the Investigator.
3. Phase 1b: 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. Phase 2: Histologically or cytologically confirmed locally advanced or metastatic selected advanced solid tumors.
4. Measurable or evaluable disease by RECIST v1.1.
5. Have adequate hematopoietic, renal and hepatic functions.
6. Men or women willing to use adequate contraceptive measures throughout the study.
Exclusion Criteria:
1. Have other prior malignancies within 3 years before the first administration.
2. Known central nervous system metastatic disease or carcinomatous meningitis except for treated and stable brain metastases.
3. Have significant, uncontrolled, or active cardiovascular disease.
4. Known history of COPD, or intestinal lung disease, or other respiratory diseases requring inpatient treatments within 4 weeks prior to first administration.
5. Have adverse events due to prior antitumor therapy not resolved to grade 1 or lower by NCI CTCAE V6.0.
6. Have active infections requiring treatment within 14 weeks; have infection of HIV, active infection of HCV and HBV.
7. Prior treatment with an antibody drug conjugate (ADC) that consists of an topoisomerase I inhibitor.
8. Prior treatment with B7-H3 targeted agents.
9. Have received any other investigational drugs or medical device within 4 weeks prior to the first administration.
10. Pregnant, or nursing females.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07466160
Study Brief:
Protocol Section:
NCT07466160