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 study is being conducted to evaluate the efficacy, safety, and ORR of HRS-4508 combination with other anti tumor therapy in subjects with solid tumor ; to evaluate HRS-4508 DLT, MTD and RP2D, to evaluate the incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0), to evaluate ORR by researchers based on RECIST v1.1, to evaluate the pharmacokinetic (PK) characteristics of HRS-4508 SHR-1811, Capecitabine.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-4508+ Capecitabine | Experimental |
| |
| HRS-4508+ Trastuzumab | Experimental |
| |
| HRS-4508+ Trastuzumab+ Pertuzumab | Experimental |
| |
| HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel | Experimental |
| |
| HRS-4508+ Trastuzumab + Nab-paclitaxel | Experimental |
| |
| HRS-4508+ Trastuzumab+ Capecitabine | Experimental |
| |
| Trastuzumab+ Capecitabine | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-4508+ Capecitabine | Drug | HRS-4508+ Capecitabine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| HRS4508 DLT | 3 weeks | |
| HRS4508 MTD | 12 weeks | |
| HRS4508 RP2D | 12 weeks | |
| The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0) | 2 years | |
| Objective response rate (ORR) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Blood concentrations of HRS-4508 | 15 weeks | |
| Blood concentrations of SHR-A1811 | 9 weeks | |
| Blood concentrations of Capecitabine |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiaman Lin | Contact | +86 180 0245 4915 | jiaman.lin@hengrui.com | |
| Yadan Huo | Contact | +86 13381110273 | Yadan.huo.yh3@hengrui.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Science | Recruiting | Beijing | Beijing Municipality | 100021 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Trastuzumab+ Pertuzumab | Active Comparator |
|
| HRS-4508+SHR-A1811 | Experimental |
|
| HRS-4508+ Trastuzumab |
| Drug |
HRS-4508+ Trastuzumab |
|
| HRS-4508+ Trastuzumab+ Pertuzumab | Drug | HRS-4508+ Trastuzumab+ Pertuzumab |
|
| HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel | Drug | HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel |
|
| HRS-4508+ Trastuzumab + Nab-paclitaxel | Drug | HRS-4508+ Trastuzumab + Nab-paclitaxel |
|
| HRS-4508+ Trastuzumab+ Capecitabine | Drug | HRS-4508+ Trastuzumab+ Capecitabine |
|
| Trastuzumab+ Capecitabine | Drug | Trastuzumab+ Capecitabine |
|
| Trastuzumab+ Pertuzumab | Drug | Trastuzumab+ Pertuzumab |
|
| HRS-4508+SHR-A1811 | Drug | HRS-4508+SHR-A1811 |
|
| 2 weeks |
| Objective response rate (ORR) | 1 year |
| Best overall efficacy (BOR) | 1 year |
| Duration of response (DoR) | 1 year |
| Progression free survival (PFS) | 1 year |
| Disease control rate (DCR) | 1 year |
| Overall survival (OS) | 2 year |
| The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0) | 2 years |
| Blood concentrations of Paclitaxel for Injection | 6 weeks |
| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
Not provided
Not provided
Not provided