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

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

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

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: QLS31903


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QLS31903<br>0.01μg/kg-2.16 μg/kg QLS31903 for injection | Drug: QLS31903<br>* 0.01μg/kg-2.16 μg/kg QLS31903 for injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose（MTD）for Phase 1a | The MTD is determined by the number of the participants in cohort who suffer a dose-limiting toxicity (DLT). The MTD is defined as the former dose at which more than one third of the participants develop a DLT. If no DLTs are observed, the MTD is not reached. | 21days or 14 days after the first target dose(whichever is longer） | 
| Recommended phase 2 dose(RP2D) for Phase 1a | The RP2D is defined as the dose level chosen by Safety Monitoring Committee(SMC) | Duration of study, approximately 24 months | 
| Objective Response Rate (ORR) for phase 1b | ORR is the percentage of patients with best response of CR and PR | From fist administration of QLS31903 to disease progression，death，loss to follow up,withdrawal of consent,initiation of a new anticancer therapy,study completion/closure,whichever came first, assessed up to 24 months |