Clinical trial · Interventional
A Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Other Therapies in Patients With HER2 Low Advanced or Metastatic Breast Cancer.
An Open, Multicenter Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Dalpiciclib, Fulvestrant, Bevacizumab or Letrozole/Anastrozole in Patients With HER2 Low Advanced or Metastatic Breast Cancer.
NCT05792410CI-TRIAL-00065229unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to evaluate the safety, tolerability, PK and preliminary anti-tumour activity of SHR-A1811 combined with other therapies in patients with HER2 low advanced or metastatic breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2 Low Advanced or Metastatic Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-A1811 & Bevacizumab injection | Drug | — | UNRESOLVED |
| SHR-A1811 & Dalpiciclib Isethionate Tablets | Drug | — | UNRESOLVED |
| SHR-A1811 & Fulvestrant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- SHR-A1811 combined with Dalpiciclib Isethionate Tablets
- interventionNames
- Drug: SHR-A1811 & Dalpiciclib Isethionate Tablets
- type
- EXPERIMENTAL
- label
- SHR-A1811 combined with Fulvestrant
- interventionNames
- Drug: SHR-A1811 & Fulvestrant
- type
- EXPERIMENTAL
- label
- SHR-A1811 combined with Bevacizumab injection
- interventionNames
- Drug: SHR-A1811 & Bevacizumab injection
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ability to give informed consent, signed and dated IRB/EC approved informed consent, willing and able to comply with treatment planning visits, tests and other procedural requirements 2. When signing the informed consent, the age is 18-75 years old (including both ends), female patients who have pathologically documented HER2 low breast cancer 3. ECOG Performance Status of 0 or 1 4. Patient must have adequate tumor sample for biomarker assessment 5. At least one measurable lesion 6. Adequate organ function Exclusion Criteria: 1. There are untreated or active central nervous system (CNS) tumor metastases 2. There was a third space effusion that could not be controlled by drainage (such as a large number of ascites, pleural effusion and pericardial effusion) 3. Major surgery within 4 weeks prior to enrollment 4. Has multiple primary malignancies within 5 years, excluding cured basal cell carcinoma of skin, cervical carcinoma in situ, papillary thyroid carcinoma, etc 5. Has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out at screening 6. Uncontrolled intercurrent illness 7. Uncontrolled or significant cardiovascular disease 8. Has known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. 9. According to NCI-CTCAE v5.0 classification, those who have not recovered to grade Ⅰ toxicity caused by previous anti-tumour treatment
References
Publications (0)
Data not yet available
No reference posted for this study.