QLS5132 Combination Therapy in Advanced Solid Tumors

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.