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This is a multicenter, open phase Ib/II clinical study, which is divided into two phases: dose exploration and efficacy expansion. Participants entering the study will receive HRS-8080 combined with Dalpiciclib Isethionate Tablets therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-8080; Dalpiciclib Isethionate Tablets | Drug | HRS-8080 combined with Dalpiciclib Isethionate Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | About 2 years | |
| Maximum tolerated dose (MTD) | About 2 years | |
| Recommended phase II dose (RP2D) | About 2 years | |
| Safety endpoints: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | About 2 years | |
| Outcome endpoint: Objective Response Rate (ORR) | About 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Steady-state peak concentration (Cmax,ss) | About 2 years | |
| Steady-state peak time (Tmax,ss) | About 2 years | |
| Steady-state valley concentration (Cmin,ss) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Li | Contact | +0518-81220121 | min.li.ml150@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital Fifth Medical Center | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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Multi-center, open clinical study of HRS-8080 in conjunction with Dalpiciclib
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| About 2 years |
| Steady-state blood drug concentration-time curve area (AUCss) | About 2 years |
| Best overall response (BOR) | About 2 years |
| Duration of response (DoR) | About 2 years |
| Disease control rate (DCR) | About 2 years |
| Clinical benefit rate (CBR) | About 2 years |
| Progression-free survival (PFS) | About 2 years |
| Sun Yat-sen University Cancer Center (SYSUCC) | Recruiting | Guangzhou | Guangdong | 510060 | China |
|
| 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 |
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