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
This study was an open, multicenter, dose-increasing/investigational Phase IB/II clinical trial to evaluate the efficacy of SHR-A1811 in combination with other antitumor therapies in subjects with advanced non-small cell lung cancer with HER2 . It can be divided into two parts, Part A is the dose escalation and efficacy exploration study of SHR-A1811 combined with Pyrotinib, and Part B is the dose escalation and efficacy exploration study of SHR-A1811 combined with SHR-1316.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-A1811 combined with Pyrotinib/SHR-A1811 combined with SHR-1316 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1811 & Pyrotinib/SHR-A1811 & SHR-1316 | Drug | Drug: SHR-A1811 & Pyrotinib SHR-A1811: intravenous Pyrotinib:oral Drug: SHR-A1811 & SHR-1316 SHR-A1811: intravenous SHR-1316: intravenous |
| Measure | Description | Time Frame |
|---|---|---|
| DLT(Phase I (dose exploration phase) main study endpoint) | 21 days after the first administration of each subject | |
| AE(Phase I (dose exploration phase) main study endpoint) | Two years after the last subject was enrolled in the group | |
| Incidence and severity of serious adverse events (SAE)(Phase I (dose exploration phase) main study endpoint) | Two years after the last subject was enrolled in the group | |
| Objective response rate(The main end points of the second stage (efficacy expansion stage)) | Two years after the last subject was enrolled in the group |
| Measure | Description | Time Frame |
|---|---|---|
| Toxin binding antibody to shr-a1811(Phase I secondary endpoint) | Two years after the last subject was enrolled in the group | |
| Total antibody to shr-a1811(Phase I secondary endpoint) | Two years after the last subject was enrolled in the group |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suqiang Yu | Contact | +0518-82342973 | suqiang.yu@hengrui.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest hospital | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
An open, multicenter, dose-increasing/investigational Phase IB/II clinical trial
Not provided
Not provided
Not provided
Not provided
| Plasma concentration of free toxin shr169265(Phase I secondary endpoint) | Two years after the last subject was enrolled in the group |
| Plasma concentration of pyrroltinib(Phase I secondary endpoint) | Two years after the last subject was enrolled in the group |
| Plasma concentration of SHR-1316(Phase I secondary endpoint) | Two years after the last subject was enrolled in the group |
| Anti shr-a1811 antibody positive(Phase I secondary endpoint) | Two years after the last subject was enrolled in the group |
| The positive status of neutralizing antibody against shr-a1811(Phase I secondary endpoint) | Two years after the last subject was enrolled in the group |
| Anti shr-1316 antibody positive(Phase I secondary endpoint) | Two years after the last subject was enrolled in the group |
| The positive status of neutralizing antibody against shr-1316(Phase I secondary endpoint) | Two years after the last subject was enrolled in the group |
| Objective Response Rate(Phase I secondary endpoint) | Two years after the last subject was enrolled in the group |
| Duration of response(Phase I secondary endpoint) | Two years after the last subject was enrolled in the group |
| Progression Free Survival(Phase I secondary endpoint) | Two years after the last subject was enrolled in the group |
| AE(Phase II secondary study endpoint) | Two years after the last subject was enrolled in the group |
| Incidence and severity of serious adverse events (SAE)(Phase II secondary study endpoint) | Two years after the last subject was enrolled in the group |
| Toxin binding antibody to shr-a1811(Phase II secondary study endpoint) | Two years after the last subject was enrolled in the group |
| Total antibody to shr-a1811(Phase II secondary study endpoint) | Two years after the last subject was enrolled in the group |
| Plasma concentration of free toxin shr169265(Phase II secondary study endpoint) | Two years after the last subject was enrolled in the group |
| Plasma concentration of pyrroltinib(Phase II secondary study endpoint) | Two years after the last subject was enrolled in the group |
| Plasma concentration of SHR-1316(Phase II secondary study endpoint) | Two years after the last subject was enrolled in the group |
| Anti shr-a1811 antibody positive(Phase II secondary study endpoint) | Two years after the last subject was enrolled in the group |
| The positive status of neutralizing antibody against shr-a1811(Phase II secondary study endpoint) | Two years after the last subject was enrolled in the group |
| Anti shr-1316 antibody positive(Phase II secondary study endpoint) | Two years after the last subject was enrolled in the group |
| The positive status of neutralizing antibody against shr-1316(Phase II secondary study endpoint) | Two years after the last subject was enrolled in the group |
| Duration of response(Phase II secondary study endpoint) | Two years after the last subject was enrolled in the group |
| Progression Free Survival(Phase II secondary study endpoint) | Two years after the last subject was enrolled in the group |
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
|