A Study of QLS31905 Combination Chemotherapy as First-Line Treatment in Patients With Advanced Solid Tumors

A Phase IB/II Clinical Study to Assess the Efficacy and Safety of QLS31905 in Combination With Chemotherapy as First-line Treatment in Patients With Claudin 18.2 (CLDN18.2) Positive Advanced Malignant Solid Tumors

This study aims to evaluate the efficacy and safety of QLS31905 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.

Inclusion Criteria:

• Subjects voluntarily participate in the study and sign the informed consent form;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
• Expected survival time ≥ 3 months;
• Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors;
• No prior systemic anti-tumor treatment for locally advanced unresectable or metastatic disease;
• Tumor tissue samples determined to have moderate-to-high Claudin18.2 expression by immunohistochemistry (IHC);
• At least one measurable lesion per RECIST v1.1;
• Patients with adequate cardiac, liver, renal function, etc.

Exclusion Criteria:

• History of malignancies other than the target cancer within 5 years prior to the first dose of the investigational product ;
• Underwent major organ surgery (excluding needle biopsy) or had significant trauma within 28 days prior to enrollment, or requires elective surgery during the study;
• Known central nervous system metastases;
• Patients with hepatitis B; patients with hepatitis C; patients who test positive for syphilis, or patients with a known history of HIV or positive HIV screening test;
• Patients with a known history of psychoactive drug abuse, alcohol abuse, or substance abuse;
• Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator and/or sponsor.