Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and anti-tumor efficacy of SKB410 for injection in patients with advanced solid tumors.
This is a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, PK profile, and anti-tumor efficacy of SKB410 for injection in patients with advanced solid tumors.This is a dose escalation study , and subjects with advanced solid tumors will be enrolled to receive SKB410 for Injection.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Several dose levels are planned in the study and administered every 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SKB410 for injection | Drug | SKB410 for injection is administered every 2 weeks (q2w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, 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 cycle 1 and is at least possibly related to study drug. | From data of initial dose until up to 28 days for treatment |
| Maximum Tolerated Dose (MTD) | MTD refers to the highest dose at which the subject's DLT incidence meets the EWOC principle (probability of DLT incidence exceeding 33% is less than 25%) during the DLT observation period. | From data of initial dose until up to 28 days for treatment |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| ORR | ORR: it refers to the proportion of subjects with best response of CR or PR after treatment. | through study completion, an average of 2 years |
| DCR | DCR: it refers to the proportion of subjects with best response of response (PR + CR) and SD after treatment. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
Not provided
| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| through study completion, an average of 2 years |
| DOR | DOR: it refers to the time from the subject's first assessment of CR or PR to disease progression or death due to any cause. | through study completion, an average of 2 years |
| PFS | PFS: it refers to the time from the start of treatment until disease progression (PD) or death. | through study completion, an average of 2 years |
| OS | OS: it refers to the time from the first dose to death due to any cause (the last follow-up time for subjects who are lost to follow-up; the end of follow-up date for subjects who are still alive at the end of the study). | through study completion, an average of 2 years |