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:
NCT07453394
Eligibility Criteria:
Inclusion Criteria:
1. Advanced solid tumors;
2. Measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1);
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
4. Adequate organ function;
5. Recover from all reversible AEs from previous anti-tumor treatment (i.e., Grade ≤ 1, according to National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] v5.0), excluding alopecia (any grade) and Grade ≤ 2 neuropathy peripheral.
Exclusion Criteria:
1. Previous treatment with drugs targeting CLDN6 (including antibody-drug conjugates \[ADCs\]), or any drug containing topoisomerase I inhibitors (including ADCs);
2. 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;
3. Progressive or symptomatic brain metastases;
4. Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection;
5. History of significant cardiac disease, or poorly controlled diabetes mellitus;
6. History of recurrent autoimmune diseases;
7. History of myelodysplastic syndrome (MDS) or Acute Myeloid Leukemia (AML);
8. History of a second primary malignancy;
9. If female, is pregnant or breastfeeding;
10. Be allergic to any component of QLS5132 or its excipients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07453394
Study Brief:
Protocol Section:
NCT07453394