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
The aim of the study to evaluate the safety and efficacy of SKB571 for injection as monotherapy in patients with locally advanced or metastatic Non-Small Cell Lung Cancer with MET abnormalities. Eligible subjects will receive SKB571 monotherapy, until radiographic disease progression, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SKB571 monotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SKB571 for injection | Drug | SKB571 for injection is administered every 3 weeks(Q3W) . |
|
| Measure | Description | Time Frame |
|---|---|---|
| AE | Incidence and severity of adverse events (AEs) | Up to 24 months |
| ORR | Objective response rate (ORR) assessed by the investigator as per RECIST v1.1. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| DCR | Disease control rate (DCR) (assessed by the investigators as per RECIST v1.1) | Up to 24 months |
| DOR | Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yina Diao | Contact | 028-67252634 | diaoyina@kelun.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pulmonary Hospital | Recruiting | Shanghai | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 24 months |
| PFS | Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors. | Up to 24 months |
| OS | Time from start of treatment to death due to any reason. | Up to 24 months |
| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided