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The study is being conducted to evaluate the tolerance, and safety of HRS-8080 tablets monotherapy and combined with other anti-cancer therapy for metastatic or local advanced breast cancer in adults. To explore the reasonable dosage of HRS-8080 tablets for metastatic or local advanced breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Group | Experimental | Firstly Dose Escalation and Dose Expansion of HRS-8080 monotherapy should be conducted. After RP2D and MTD of the HRS-8080 monotherapy were confirmed, Dose Escalation and Dose Extension of HRS-8080 in combination with other anti-cancer treatment would be completed, including SHR 6390, or Abemaciclib, or Everolimus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-8080 tablets、SHR 6390 tablets、Abemaciclib、Everolimus | Drug | During HRS-8080 monotherapy period, the dose of HRS-8080 would be increasing. In the combination therapy period, HRS-8080 will be administered at flat dose of RP2D-1 and RP2D. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose | The Maximum tolerated dose of HRS-8080 monotherapy or in combination with SHR-6390 / Abemaciclib / Everolimus | up to 28 days |
| Recommended phase II dose | The Recommended phase II dose of HRS-8080 monotherapy or in combination with SHR-6390 / Abemaciclib / Everolimus | up to 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-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus. | 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period |
| Tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fifth Medical Center of People's Liberation Army of China General Hospital | Beijing | Beijing Municipality | 100071 | China | ||
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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HRS-8080 tablets monotherapy and combined with other anti-cancer therapy
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PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus. etc. |
| 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period |
| AUC0-t | PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus. | 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period |
| Cmax,ss | PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus. | 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period |
| Tmax,ss | PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus. | 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period |
| Cmin,ss | PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus. | 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period |
| AUCss | PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus. | 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period |
| Rac | PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus. | 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period |
| ORR | Objective Response Rate, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer | from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months |
| BOR | Best Overall Response, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer | from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months |
| DoR | Duration of response, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer | from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months |
| DCR | Disease control rate, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer | from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months |
| PFS | Progression-free survival, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer | from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months |
| Jilin Cancer Hospital |
| Changchun |
| Jilin |
| 130012 |
| China |