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

• Status: Recruiting
• Trial end date: 2027-06-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Criteria

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