RecruitingPhase 1NCT05823285

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

Sponsor

Qilu Pharmaceutical Co., Ltd.

Enrollment

150 participants

Start Date

Mar 22, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumors

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria6

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