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
Not provided
The phase 1/2 clinical study includes three stages: Phase 1 dose escalation, phase 1 PK expansion and phase 2 cohort expansion:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy Dose Finding | Experimental |
| |
| PK expansion as Monotherapy | Experimental |
| |
| Cohort expansion as Monotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLS5133 | Drug | antibody drug conjugate (ADC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events and serious adverse events | Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0 | up to 2 years |
| Maximum tolerated dose (MTD) | Highest administered dose with < 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants | 28days |
| Recommended Phase 2 Dose (RP2D) | Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data | up to 2 years |
| Objective Response Rate (ORR) | Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1 | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Serum Concentration of QLS5133 (Cmax) | PK assessment | 21 days |
| Maximum Serum Concentration of QLS5133 at Steady State (Cmax,ss) | PK assessment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaohua Wu, PhD | Contact | 021-64175590-88503 | JJYIN555@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 63 days |
| Minimum Serum Concentration of QLS5133 at Steady State (Cmin,ss) | PK assessment | 63 days |
| Time of Maximum Serum Concentration of QLS5133 (Tmax) | PK assessment | 21 days |
| Terminal Half-life (T1/2) of Serum QLS5133 | PK assessment | 63 days |
| Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUC0-t) for QLS5133 | PK assessment | 21 days |
| Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUC0-∞) for QLS5133 | PK assessment | 63 days |
| Apparent Volume of Distribution (Vd) of QLS5133 | PK assessment | 63 days |
| Clearance (CL) of QLS5133 | PK assessment | 63 days |
| Duration of Response (DOR) | Time from CR or PR to objective disease progression or death to any cause | up to 2 years |
| Progression Free Survival (PFS) | PFS is defined as the time from the start of the treatment until objective disease progression or death from any cause | up to 2 years |
| Time to Progression (TTP) | Time from start of treatment to disease progression | 1 years |
| 1 Year Overall Survival (1YOS) | Proportion of participants alive at 1 year from the start of treatment to death from any cause | 1 years |
| 2 Year Overall Survival (2YOS) | Proportion of participants alive at 2 years from the start of treatment to death from any cause | 2 years |
| Number of anti-drug antibody (ADA) Positive Participants | Immunogenicity will be measured by the number of participants that are ADA positive | up to 2 years |
| Number of neutralizing antibody (Nab) Positive Participants | Immunogenicity will be measured by the number of participants that are Nab positive | up to 2 years |