A Study to Evaluate Claudin 18.2-Directed ADC LCB02A in Advanced Solid Tumors

Inclusion Criteria

• •Phase 1 Dose Escalation: histologically or cytologically confirmed advanced solid tumors that are Claudin 18.2 positive and refractory to standard of care treatment.
• •Phase 2 Dose Expansion: selected histologically or cytologically confirmed advanced solid tumors that are Claudin 18.2 positive and refractory to standard of care treatment. Expansion cohort indications will be prioritized based on data from the Phase 1 dose escalation portion.
• •Prior treatment with Claudin 18.2 directed therapy is permitted.
• •Measurable disease as defined by RECIST v1.1
• •Willingness to provide archival tumor tissue when available, or to undergo a pre-treatment biopsy if archival tissue is not available.
• •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• •Adequate organ function as defined by:
• •* Absolute neutrophil count ≥ 1.5 × 109/L , without colony stimulating factor support for the past 14 days
• •* Platelet count ≥ 100 × 109/L
• •* Hemoglobin level ≥ 9.0 g/dL
• •* Total bilirubin ≤ 1.5× upper limit of normal (ULN) or \<3 x ULN with Gilbert's syndrome or liver metastases at baseline
• •* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5× ULN (≤ 5.0× ULN for subjects with liver metastases)
• •* Albumin ≥ 2.5 g/dL
• •* Serum creatinine ≤ 1.5× ULN or creatinine clearance ≥ 50 mL/min