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This is a phase I/II clinical study to evaluate the safety and efficacy of SKB565 in participants with advanced solid tumors. The study includes a dose escalation stage, a dose expansion stage, and a indication expansion stage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SKB565 monotherapy | Experimental | SKB565 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SKB565 | Drug | IV infusion on Day 1 and Day 15 of each cycle, every 4 weeks (Q4W), until radiographic disease progression (PD), intolerable toxicity, participant request for discontinuation, lost to follow-up, or death (whichever occurs first). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects achieving Dose-limiting toxicity (DLT) | DLT is defined as an adverse event (AE) that meets protocol-defined DLT criteria during the first 28 days and is at least possibly related to the study drug. | Day 1 to Day 28 in Cycle 1 in the dose escalation part |
| Objective response rate (ORR) | To evaluate the ORR of SKB565 as assessed by the investigator based on RECIST v1.1. | Up to approximately 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Qing | Contact | 028-67255480 | qingyan@kelun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 510060 | China |
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| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510289 | China |
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