Breast Cancer
Conditions
Brief summary
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).
Interventions
DRUGHRS-1358
HRS-1358 or combination with Dalpiciclib Isethionate Tablets will be administered daily orally in continuous dosing over 28-day cycles.
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm study of HRS-1358
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically diagnosis of local advanced or metastatic breast cancer 2. Women must be postmenopausal, or pre-/peri-menopausal women must be on ovarian suppression 3. At least 1 line of endocrine therapy in the metastatic or advanced setting 4. ECOG performance status score: 0-1; 5. Adequate organ functions as defined 6. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study.
Exclusion criteria
1. the investigators judged that it was not suitable to endocrine therapy 2. patients with active brain metastasis (without medical control or with clinical symptoms), 3. History of clinically significant cardiovascular or cerebrovascular diseases 4. The subject has one of many factors affecting oral 、absorption, distribution, metabolism and excretion of drugs 5. Active autoimmune diseases, History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation 6. Have received other similar drugs in the past; 7. Known history of allergy to HRS-1358 ingredients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limited Toxicities (DLTs) | up to 28 days | Number of participants with dose-limiting toxicities (DLTs) |
| Maximum tolerated dose | up to 28 days | The Maximum tolerated dose of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets |
| RP2D | Change From Baseline at 28 days | select the Recommended Phase 2 Dose (RP2D) of HRS-1358 or combination with Dalpiciclib Isethionate Tablets |
| Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) | up to 30 days after the last dose | Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax,ss | 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period | PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets |
| Cmin,ss | 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period | PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets |
| AUCss | 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period | PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets |
| Rac | 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period | PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets |
| Cmax | 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period | PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets |
| 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 | — |
| Overall response rate (ORR) in participants | Up to approximately 1 year | — |
| Tmax | 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period | PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets |
| AUC0-t | 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period | PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets |
| Cmax,ss | 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period | PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets |
Countries
China
Contacts
Primary ContactXia Zhang
Outcome results
None listed