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This study is a phase I, dose escalation and dose expansion study of QLS1103, to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of QLS1103 in subjects with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLS1103 Dose Escalation and Expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLS1103 | Drug | Oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) | 21 Days (first cycle) | |
| Recommended dose for phase II (RP2D) | Up to 24 approximately months | |
| Adverse events(AEs) / Serious adverse events(SAEs) | Up to 24 approximately months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of QLS1103 | Up to approximately 2 years | |
| Time of maximum observed plasma concentration (Tmax) of QLS1103 | Up to approximately 2 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qing Shao | Contact | +8615221936606 | qing1.shao@qilu-pharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Yilong Wu, MD | Guangdong Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| Area under the plasma concentration-time curve (AUC) of QLS1103 |
| Up to approximately 2 years |
| Objective response rate (ORR) | Up to approximately 2 years |
| Disease control rate (DCR) | Up to approximately 2 years |
| Duration of response (DOR) | Up to approximately 2 years |
| Progression free survival (PFS) | Up to approximately 2 years |