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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT06932094
Eligibility Criteria:
Inclusion Criteria:
* Advanced solid tumors;
* Measurable disease, per RECIST v1.1;
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
* Adequate organ function;
* Recover from all reversible AEs from previous anti-tumor treatment (i.e., Grade ≤ 1, according to NCI-CTCAE v5.0), excluding alopecia (any grade) and Grade ≤ 2 neuropathy peripheral;
Exclusion Criteria:
* Previous treatment with drugs targeting CLDN6 (including ADCs), or any drug containing topoisomerase I inhibitors (including ADCs);
* Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 2 weeks with small molecule and within 4 weeks with biologic before the first dose of QLS5132;
* Progressive or symptomatic brain metastases;
* Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection;
* History of significant cardiac disease, or poorly controlled diabetes mellitus;
* History of recurrent autoimmune diseases;
* History of myelodysplastic syndrome (MDS) or AML;
* History of other active malignant tumors within 3 years before signing the informed consent form;
* If female, is pregnant or breastfeeding;
* Be allergic to any component of QLS5132 or its excipients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06932094
Study Brief:
Protocol Section:
NCT06932094