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 is designed to determine if treatments with the combination of HRS-8080 and SHR-A1811, the combination of HRS-8080 and SHR-A2009, the combination of SHR-A2009 and SHR-1316 are safe, tolerable, and has anti-cancer activity in patients with unresectable or metastatic breast cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental |
| |
| Part B | Experimental |
| |
| Part C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-8080; SHR-A1811 | Drug | Participants will receive HRS-8080 and SHR-A1811 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limited Toxicity(DLT) | Phase 1 | up to 1 cycle (21 days) |
| Maximum Tolerable Dose(MTD) | Phase 1 | up to 1 cycle (21 days) |
| Recommended Phase 2 Dose(RP2D) | Phase 1 | up to 1 cycle (21 days) |
| Safety endpoints: the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (rated based on CTCAE V5.0) | Phase 1 | up to 12 months |
| Efficacy endpoint: objective response rate (ORR) | Phase 2 | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| level of SHR-A1811 ADA and Nab | Phase 1 | up to 12 months |
| level of SHR-A2009 ADA and Nab | Phase 1 | up to 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Na An | Contact | +86 18500038119 | na.an@hengrui.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410031 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Three parallel arms
Not provided
Not provided
Not provided
Not provided
| HRS-8080; SHR-A2009 |
| Drug |
Participants will receive HRS-8080 and SHR-A2009 |
|
| SHR-A2009; SHR-1316 | Drug | Participants will receive SHR-A2009 and SHR-1316 |
|
| level of adebrelimab ADA and Nab | Phase 1 | up to 12 months |
| Objective response rate (ORR) | Phase 1 | up to 12 months |
| Best overall response (BOR) | Phase 1 | up to 12 months |
| Duration of response (DoR) | Phase 1 | up to 12 months |
| Disease control rate (DCR) | Phase 1 | up to 12 months |
| Clinical benefit rate (CBR) | Phase 1 | up to 12 months |
| Progression-free survival (PFS) | Phase 1 | up to 12 months |
| Safety endpoints: incidence and severity of AEs and SAEs (rated based on CTCAE V5.0) | Phase 2 | up to 12 months |
| level of SHR-A1811 ADA and Nab | Phase 2 | up to 12 months |
| level of SHR-A2009 ADA and Nab | Phase 2 | up to 12 months |
| level of adebrelimab ADA and Nab | Phase 2 | up to 12 months |
| Best overall response (BOR) | Phase 2 | up to 12 months |
| Duration of response (DoR) | Phase 2 | up to 12 months |
| Disease control rate (DCR) | Phase 2 | up to 12 months |
| Clinical benefit rate (CBR) | Phase 2 | up to 12 months |
| Progression-free survival (PFS) | Phase 2 | up to 12 months |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided