A Study of QLS5133 Monotherapy in Advanced Solid Tumors

Inclusion criteria

• Aged ≥ 18 years on the day of signing the ICF, male or female;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0 or 1;
• Measurable disease, per RECIST v1.1;
• 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, or who experience other abnormalities that are not clinically significant or toxicities judged to have no risk by the investigator;
• Left ventricular ejection fraction (LVEF) ≥ 50%;

Exclusion criteria

• Previous treatment with drugs targeting CDH6 (including ADCs), or any drug containing topoisomerase I inhibitors (including ADCs);
• Large and uncontrollable pleural, pericardial or abdominal effusion before the first dose (those who are stable for at least 2 weeks after drainage can be enrolled);
• Progressive or symptomatic brain metastases;
• Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month before the first dose
• History of significant cardiac disease, or poorly controlled diabetes mellitus;
• History of recurrent autoimmune diseases;
• History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (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 QLS5133 or its excipients.