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 @ 5:50 PM
Ignite Modification Date:
2025-12-24 @ 5:50 PM
NCT ID:
NCT05360368
Eligibility Criteria:
Inclusion Criteria:
* Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF);
* Aged ≥ 18 years, ≤ 75 years;
* Patients must have histologically confirmed malignant solid tumors which are advanced or metastatic, have failed prior standard treatment, and be intolerant or ineligible for standard therapy;
* Measurable disease according to RECIST Version 1.1;
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
* Expected survival 12 weeks;
* Adequate organ function;
* For fertile female subjects, the pregnancy test must be negative within 7 days before the first dose;
Exclusion Criteria:
* Prior anti-EGFR (including EGFR ADC) monoclonal antibody therapy;
* A history of other malignancies within two years, except for cured Localized tumor;
* Participants with any prior allogeneic solid organ or bone marrow transplantations;
* Symptomatic brain or meningeal metastases (unless the patient has been on \> treatment for 3 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable);
* Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
* Active clinical severe infection;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05360368
Study Brief:
Protocol Section:
NCT05360368