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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT07197827
Eligibility Criteria:
Inclusion Criteria:
* Aged ≥18 years.
* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
* Adequate organ and bone marrow function
* Tumor type:
Part 1-3: Advanced/unresectable or metastatic solid malignant tumor; Have received at least one prior line of systemic anti-tumor therapy
Part 4: locally advanced or metastatic non-sq NSCLC without AGA and HCC; Have not received any systemic anti-tumor therapy;
Part 5: mCRC, have received at least one (5a) or one (5b) prior line of systemic anti-tumor therapy
Part 6: advanced or metastatic HER2-negative G/GEJ; have received at least one (6a) or one (6b) prior line of systemic anti-tumor therapy
Exclusion Criteria:
* Be intolerant to prior treatment with a topoisomerase I inhibitor or an ADC that consists of a topoisomerase I inhibitor
* Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases
* Clinically significant concomitant pulmonary disease
* A history of leptomeningeal carcinomatosis or carcinomatous meningitis
* Any illness, medical condition, organ system dysfunction, or social situation, including but not limited to mental illness or substance/alcohol abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07197827
Study Brief:
Protocol Section:
NCT07197827