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

Hengrui Medicine

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: HER2 Low Advanced or Metastatic Breast Cancer

Treatments: Drug: SHR-A1811 & Fulvestrant; Drug: SHR-A1811 & Dalpiciclib Isethionate Tablets; Drug: SHR-A1811 & Bevacizumab injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05792410

SHR-A1811-206

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

SHR-A1811 combined with Dalpiciclib Isethionate Tablets

Experimental group

Treatment:

Drug: SHR-A1811 & Dalpiciclib Isethionate Tablets

SHR-A1811 combined with Fulvestrant

Experimental group

Treatment:

Drug: SHR-A1811 & Fulvestrant

SHR-A1811 combined with Bevacizumab injection

Experimental group

Treatment:

Drug: SHR-A1811 & Bevacizumab injection