A Study Evaluates the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLS31903 in Advanced Solid Tumor Patients

A Phase 1 Study to Investigate the Safety, Tolerability，Pharmacokinetics, Immunogenicity and Preliminary Effectiveness of QLS31903 Injection in Subjects With Advanced Solid Tumors

The purpose of the study is to evaluate safety, pharmacokinetics,immunogenicity and efficacy of QLS31903 alone in the treatment of advanced cancer.

Key Inclusion Criteria:

• 18 years or older, 40kg or heavier
• Histologically or cytologically confirmed diagnosis of advanced solid tumor （For phase 1b, patients must have solid tumor with GPC3+ )
• Standard treatment failed or standard treatment intolerant, no standard treatment
• Adequate hepatic, hematologic, and renal function

Key Exclusion Criteria:

• Anti-tumor treatment within 4 weeks prior to the first QLS31903 administration,except a few specific conditions
• Other clinical trial within 4 weeks prior to the first QLS31903 administration
• Receipt of a live or live attenuated vaccine within 30 days prior to the first QLS31903 administration
• Prior treatment targeted on GPC3
• HBsAg/HBcAb positive and HBV-DNA>10,000 copy/mL;HCV-Ab positive and HCV-RNA>1,000 copy/mL
• CNS metastasis (except asymptomatic brain metastases or symptomatic brain metastases after treatment stable for more than 4 weeks) and/or carcinomatous meningitis or leptomeningeal disease