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The goal of this Phase I study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of QLS5308 monotherapy in participants with Advanced Solid Tumors. This study is divided into two phases: Phase Ia is the dose escalation phase, where dose escalation of QLS5308 conducted and RP2D is explored; In the Phase Ib tumor type expansion study stage, the primary objective is to evaluate the objective response rate (ORR) of QLS5308 with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: QLS5308 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLS5308 IV infusion | Drug | Participants will receive escalating doses of QLS5308 (0.8, 1.6, 3.2, 4.0, 4.8, 5.6, 6.4 mg/kg) intravenously on Day 1 of each 21-day cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| The maximum tolerated dose (MTD)/maximum administration dose (MAD) and RP2D of QLS5308 in patients with advanced solid tumors. | up to 12 months | |
| Number of participants who experience one or more adverse events(AEs). | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | up to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by investigator. | up to 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shusen Wang, Doctor | Contact | 13926168469 | Wangshus@susucc.org.cn |
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| DOR | For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1), DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by investigator. | up to 48 months |
| PFS | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version1.1 (RECIST 1.1). PD is defined as ≥20%increase in the sum of diameters of target lesions. In addition to the relative increase of20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearanceof one or more new lesions is alsoconsidered PD. PFS as assessed by investigator. | up to 48 months |
| OS | OS is defined as the time from randomization to death due to any cause. | up to 60 months |