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Trial Title:
A Trial of HRS-1358 Tablets in Metastatic or Local Advanced Breast Cancer
NCT ID:
NCT05628870
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single arm study of HRS-1358
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HRS-1358
Description:
HRS-1358 or combination with Dalpiciclib Isethionate Tablets will be administered daily
orally in continuous dosing over 28-day cycles.
Arm group label:
HRS-1358
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).
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Investigator:
Last name:
Binghe Xu
Email:
Principal Investigator
Start date:
February 7, 2023
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Shandong Suncadia Medicine Co., Ltd.
Agency class:
Industry
Source:
Shandong Suncadia Medicine Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05628870
