Phase Ib/II Clinical Study of QLS5133 Combination Therapy in Advanced Solid Tumors

Inclusion Criteria:

• 1. Histologically or cytologically confirmed advanced solid tumors, with specific tumor type and prior treatment requirements per each cohort;
• 2. Measurable disease per RECIST v1.1 (except Cohorts 3B-1, 3B-2, and 5B);
• 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 NCI-CTCAE v6.0), excluding alopecia (any grade) and Grade ≤ 2 neuropathy peripheral;.

Exclusion Criteria:

• 1.Prior treatment with CDH6-targeted agents or topoisomerase I inhibitors (including ADCs);
• 2.Prior treatment with immune checkpoint inhibitors (for Cohorts 2 and 6 only);
• 3.Prior Grade 4 or persistent ≥ 4-week Grade 3 immune-related AEs from immune checkpoint inhibitors;
• 4.Prior systemic anti-tumor therapy (for Cohorts 1B-2 and 2B-2 only);
• 5.Recent anti-tumor therapy within specified washout periods (small molecules: 2 weeks; biologics/chemotherapy: 4 weeks; mitomycin/nitrosoureas: 6 weeks);
• 6.Active or symptomatic CNS metastases or leptomeningeal carcinomatosis;
• 7. Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection;
• 8.History of significant cardiac disease, or poorly controlled diabetes mellitus;
• 9.History of recurrent autoimmune diseases;
• 10. History of a second primary malignancy;
• 11.Be allergic to any component of QLS5133 or its excipients.