Testing HRS-1358 Tablets for Advanced Breast Cancer
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.
This study is testing a new tablet called HRS-1358, alone and with another drug, to see if it can be a safe and effective treatment for people with advanced breast cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Shandong Suncadia Medicine Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05628870 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and tolerability of HRS-1358, both as a standalone treatment and in combination with Dalpiciclib Isethionate, for patients with metastatic or locally advanced breast cancer. The study aims to determine the Dose-Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD), and to identify the Recommended Phase 2 Dose (RP2D). Participants will be closely monitored to assess the drug's effects and any potential side effects.
Who should consider this trial
Good fit: Ideal candidates include postmenopausal women or pre-/peri-menopausal women on ovarian suppression with a diagnosis of local advanced or metastatic breast cancer who have received at least one line of endocrine therapy.
Not a fit: Patients with active brain metastasis, significant cardiovascular or cerebrovascular diseases, or those unsuitable for endocrine therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced breast cancer.
How similar studies have performed: While this specific combination is being tested for the first time, similar approaches in targeting advanced breast cancer have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality
- Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xia Zhang
- Email: Xia.zhang@hengrui.com
- Phone: +0518-81220121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.