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
Q-1802 is a bispecific antibody targeting both the tumor-specific antigen Claudin 18.2 and the immune checkpoint PD-L1. This is a multi-center, single-arm, open-label design to evaluate the safety and tolerance of Q-1802 in patients with advanced solid tumors, together with an assessment of pharmacokinetic characteristics and efficacy. The study consisted of two compartments: the dose-exploration stage and the dose-extension stage.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Q-1802 | Experimental | Q-1802 dose exploration and Q-1802 dose extension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Q-1802 | Drug | Q-1802 will be administered intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with dose limiting toxicities | Incidence of dose limiting toxicities(DLTs). A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle with Q-1802. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration (Cmax) | Highest observed plasma concentration of Q-1802 | 70 days |
| Time to achieve Cmax (Tmax) | Time of highest observed plasma concentration of Q-1802 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xu Liang | Contact | 021-50920280 | liangxu@qurebio.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing cancer hospical | Recruiting | Beijing | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 70 days |
| Area under the plasma concentration-time curve (AUC) | Area under the plasma concentration time curve of Q-1802 | 70 days |
| PD-L1 receptor occupancy rate (RO) | PD-L1 receptor occupancy rate (RO) on the surface of T lymphocytes in peripheral blood at different time points of Q-1802 | 70 days |
| Number of participants with treatment-related adverse events(TRAE) | TRAE is defined as the AEs that the casual relationship of the AE is ralated to Q-1802. | 70 days |
| Objective response rate (ORR) | ORR is defined as proportion of participants with complete response, partial response (CR+PR). | 70 days |
| Progression-free survival (PFS) | PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first. | 70 days |
| Duration of response ( DCR ) | DCR is defined as proportion of participants with complete response, partial response, stable disease (CR+PR+SD). | 70 days |
| Duration of response ( DOR ) | DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first | 70 days |
| West China Second University Hospical, Sichuan University | Recruiting | Chengdu | China |
|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | China |
|
| PKUCare Luzhong Hospital | Recruiting | Zibo | China |
|