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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLS31903 | Experimental | 0.01μg/kg-2.16 μg/kg QLS31903 for injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLS31903 | Drug | 0.01μg/kg-2.16 μg/kg QLS31903 for injection |
|
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Chen, PhD | Contact | 8617843558626 | yan12.chen@qilu-pharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoyan Kang, PhD | Qilu Pharmaceutical Co., Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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