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The study is being conducted to evaluate the safety and tolerability of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets in patients with metastatic or locally advanced breast cancer in order to estimate the Dose-Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and select the Recommended Phase 2 Dose (RP2D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-1358 | Experimental | Daily oral dosages of HR-1358; Daily oral dosages of HR-1358 and Dalpiciclib Isethionate Tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-1358 | Drug | HRS-1358 or combination with Dalpiciclib Isethionate Tablets will be administered daily orally in continuous dosing over 28-day cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limited Toxicities (DLTs) | Number of participants with dose-limiting toxicities (DLTs) | up to 28 days |
| Maximum tolerated dose | The Maximum tolerated dose of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets | up to 28 days |
| RP2D | select the Recommended Phase 2 Dose (RP2D) of HRS-1358 or combination with Dalpiciclib Isethionate Tablets | Change From Baseline at 28 days |
| Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) | Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | up to 30 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets | 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period |
| Tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xia Zhang | Contact | +0518-81220121 | Xia.zhang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Single arm study of HRS-1358
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PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
| 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period |
| AUC0-t | PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets | 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period |
| Cmax,ss | PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets | 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period |
| Tmax,ss | PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets | 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period |
| Cmin,ss | PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets | 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period |
| AUCss | PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets | 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period |
| Rac | PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets | 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period |
| Overall response rate (ORR) in participants | Up to approximately 1 year |
| Clinical benefit rate (CBR) in participants | Up to approximately 1 year |
| Duration of response (DOR) in participants | Up to approximately 1 year |
| Progression Free Survival (PFS) observed in participants | Up to approximately 1 year |
| D017437 |
| Skin and Connective Tissue Diseases |