A Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Other Therapies in Patients With HER2 Low Advanced or Metastatic Breast Cancer.

• Status: Not yet recruiting
• Trial end date: 2025-02-27
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Bevacizumab; Fulvestrant

Criteria

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