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 is a multicenter, phase 2, open label study to evaluate safety, tolerability and efficacy of SHR2554 combined with other anti-tumor treatments in patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Experimental |
| |
| Treatment group C | Experimental |
| |
| Treatment group D | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR2554 Tablets | Drug | Oral SHR2554 tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs). | Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. | Up to approximately 2 years. |
| Incidence and severity of serious adverse events (SAEs). | Incidence and severity of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. | Up to approximately 2 years. |
| Incidence of Dose Limited Toxicity (DLT). | Up to Day 21. | |
| Objective response rate (ORR) by the investigator assessment. | Defined as percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) assessed by the investigator. | Up to approximately 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of objective tumor response (DoR). | Approximately 24 months. | |
| Disease control rate (DCR). | Approximately 24 months. | |
| Progression-free survival (PFS). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Botao Zhu | Contact | +86-021-23511999 | botao.zhu.bz19@hengrui.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbin Medical University Cancer Hospital | Recruiting | Harbin | Heilongjiang | 150081 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| SHR-A1811 Injection | Drug | SHR-A1811 for injection. |
|
| SHR-A1904 Injection | Drug | SHR-A1904 for injection. |
|
| SHR-1701 Injection | Drug | SHR-1701 injection |
|
| Approximately 24 months. |
| Overall survival (OS) assessed by the investigator. | Approximately 24 months. |
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
|
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000723862 | SHR-1701 |
Not provided
Not provided
Not provided