NCT04993430Active, not recruitingPhase 1
A Phase 1 Study of HRS8807 Monotherapy and in Combination With SHR6390 in Subjects With ER-Positive, HER2-Negative Metastatic or Locally Advanced Breast Cancer
A Phase 1, Single Arm, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability and Pharmacokinetic of HRS8807 Monotherapy and in Combination With SHR6390 in Subjects With ER-Positive, HER2-Negative Metastatic or Locally Advanced Breast Cancer
Source: ClinicalTrials.gov · Last updated 28 May 2026
Brief summary (registry, in English)
The study is to assess safety and tolerability of HRS8807 monotherapy and in combination with SHR6390 in subjects 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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 46 (actual)
- First submitted
- 20 Jul 2021
- Start date
- 26 Oct 2021
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Diseases
- Metastatic breast cancer
- NCT number
- NCT04993430
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 46
- From 26 Oct 2021 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- All patients in monotherapy and or in combination wih phase who are known allergic to HRS8807 or SHR6390 ingredient;
- Presence of symptomatic metastatic visceral disease ;
- Clinically serious cardiovascular disease;
- Active infection or unexplained fever \>38.5℃ during screening period or on the day of the first dose.
Lab values
- Abnormal thyroid function laboratory results;
Other
- Patients with known active brain metastases;
- Abnormal electrocardiographic (ECG) with clinical significancy by investigator judgement;
Who the study is looking for
- Histological diagnosis of metastatic or locally advanced breast cancer; Histologically proven diagnosis of ER-positive, HER2-negative;
- At least 1 line of endocrine therapy in the metastatic or advanced setting that had progressed or intolerance; ≤ 2 lines of chemotherapy for metastatic or advanced disease;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1;
- Expected survival of more than 3 months.
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.