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This is a phase 1/2 clinical study to evaluate the safety and efficacy of SKB103 in participants with advanced solid tumors. The study includes a dose escalation stage, a dose expansion stage, and a indication expansion stage.
This is a multi-center, open-label, phase 1/2 clinical study to evaluate the safety, tolerability, pharmacokinetics (PK) characteristics, immunogenicity, and efficacy of SKB103 in participants with advanced solid tumors. The study includes a Phase 1 dose escalation stage, a Phase 1 dose expansion stage, and a Phase 2 indication expansion stage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SKB103 monotherapy | Experimental | Participants will be dosed with SKB103 for injection every 3 weeks(q3w) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SKB103 for injection monotherapy | Drug | IV infusion on Day 1 of each cycle, every 3 weeks (Q3W), 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 21 days and is at least possibly related to the study drug. | From date of initial dose until up to 21 days for treatment |
| Objective response rate (ORR) | The sum of the number of cases with Complete Response (CR) and Partial Response (PR) in all treated tumor patients (CR + PR) divided by the total number of cases. | Up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors. | Up to approximately 3 years |
| Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yina Diao | Contact | 86-028-67252634 | diaoyina@kelun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbin Medical University Cancer Hospital | Recruiting | Harbin | Heilongjiang | 150001 | China |
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Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.
| Up to approximately 3 years |
| Overall Survival (OS) | Time from start of treatment to death due to any reason. | Up to approximately 3 years |
| Maximum observed plasma concentration (Cmax) of SKB103-ADC, SKB103-TAB, and free KL610348. | Pharmacokinetic (PK) parameters of SKB103-ADC, SKB103-TAB, and free KL610348. | Up to approximately 3 years |
| Shanghai East Hospital, Tongj.University | Recruiting | Shanghai | Shanghai Municipality | 200123 | China |
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