Recruiting NCT05628870
A Trial of HRS-1358 Tablets in Metastatic or Local Advanced Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-1358.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single-arm, Open-label, Multi-center Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HRS-1358 Monotherapy or Combination With Dalpiciclib Isethionate Tablets in Patients With Metastatic or Locally Advanced Breast Cancer.
Overview
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
- Drug HRS-1358
HRS-1358 or combination with Dalpiciclib Isethionate Tablets will be administered daily orally in continuous dosing over 28-day cycles.
Primary outcome measures
- Dose Limited Toxicities (DLTs) [Time frame: up to 28 days]
- Maximum tolerated dose [Time frame: up to 28 days]
- RP2D [Time frame: Change From Baseline at 28 days]
- Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) [Time frame: up to 30 days after the last dose]
Secondary outcome measures (12)
- Cmax [Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period]
- Tmax [Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period]
- AUC0-t [Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period]
- Cmax,ss [Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period]
- Tmax,ss [Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period]
- Cmin,ss [Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period]
- AUCss [Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period]
- Rac [Time frame: 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 [Time frame: Up to approximately 1 year]
- Clinical benefit rate (CBR) in participants [Time frame: Up to approximately 1 year]
- Duration of response (DOR) in participants [Time frame: Up to approximately 1 year]
- Progression Free Survival (PFS) observed in participants [Time frame: Up to approximately 1 year]
Eligibility criteria
Inclusion criteria
- Histologically diagnosis of local advanced or metastatic breast cancer
- Women must be postmenopausal, or pre-/peri-menopausal women must be on ovarian suppression
- At least 1 line of endocrine therapy in the metastatic or advanced setting
- ECOG performance status score: 0-1;
- Adequate organ functions as defined
- Ability to understand and voluntarily agrees to participate by giving written informed consent for the study.
Exclusion criteria
- the investigators judged that it was not suitable to endocrine therapy
- patients with active brain metastasis (without medical control or with clinical symptoms),
- History of clinically significant cardiovascular or cerebrovascular diseases
- The subject has one of many factors affecting oral 、absorption, distribution, metabolism and excretion of drugs
- Active autoimmune diseases, History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation
- Have received other similar drugs in the past;
- Known history of allergy to HRS-1358 ingredients
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing
Identifiers
NCT: NCT05628870 · HRS-1358-I-101