A Trial of HRS-8080 Tablets in Metastatic or Local Advanced Breast Cancer of Adults
- Summary
- 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.
- Short title
- A Trial of HRS-8080 Tablets in Metastatic or Local Advanced Breast Cancer of Adults
- Official title
- A Single-arm, Open-label and Multi-center Phase I Study on Safety, Tolerance and Pharmacokinetics of HRS-8080 Tablets Monotherapy and Combined With Other Anti-cancer Therapy in Patients With Metastatic or Local Advanced Breast Cancer
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2025-07-31
- First posted
- 2022-01-12
- Registry last updated
- 2022-04-05
- Primary completion date
- 2024-10-31
- Start date
- 2022-02-17
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05189717
- ClinicalTrials.gov ID
- NCT05189717
- Registry record
- Open registry record
- Allocation
- Not applicable
- Model
- Single group
- Purpose
- Treatment
- Masking
- No masking
Maximum tolerated dose
Timeframe: up to 28 days
The Maximum tolerated dose of HRS-8080 monotherapy or in combination with SHR-6390 / Abemaciclib / Everolimus
Recommended phase II dose
Timeframe: up to 28 days
The Recommended phase II dose of HRS-8080 monotherapy or in combination with SHR-6390 / Abemaciclib / Everolimus
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
Timeframe: 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
Cmax
Timeframe: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Tmax
Timeframe: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus. etc.
AUC0-t
Timeframe: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Cmax,ss
Timeframe: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Tmax,ss
Timeframe: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Cmin,ss
Timeframe: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
AUCss
Timeframe: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Rac
Timeframe: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
ORR
Timeframe: 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
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
BOR
Timeframe: 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
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
DoR
Timeframe: 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
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
DCR
Timeframe: 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
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
PFS
Timeframe: 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
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
- Sex
- Female
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- ECOG performance status score: 0-1;
- Histopathologically documented local advanced or metastatic breast cancer ;
- Female of not childbearing potential must the related requirement;
- During or after the last systematic therapy before enrolment, disease progression occurred with clinical or radiographical documentation;
- Adequate organ functions as defined;
- Ability to understand and voluntarily agrees to participate by giving written informed consent for the study.
- For the case of symptomatic visceral metastasis, the investigators judged that it was not suitable to use relevant treatment;
- patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, spinal cord compression, or patients with a history of primary tumors of the central nervous system ;
- History of clinically significant cardiovascular or cerebrovascular diseases;
- The subject has one of many factors affecting oral drugs;
- Active infection or fever with unknown cause > 38.5 °C;
- Active autoimmune diseases, History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
- Known history of allergy to study drug ingredients.
- Fifth Medical Center of People's Liberation Army of China General HospitalBeijing, China
- Jilin Cancer HospitalChangchun, China