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Trial Title:
A Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Other Therapies in Patients With HER2 Low Advanced or Metastatic Breast Cancer.
NCT ID:
NCT05792410
Condition:
HER2 Low Advanced or Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Bevacizumab
Fulvestrant
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
An open, multicenter, dose-finding and dose expansion investigational Phase IB/II
clinical trial
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A1811 & Dalpiciclib Isethionate Tablets
Description:
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Dalpiciclib
Isethionate Tablets：Tablet, 25mg / tablet, 50mg / tablet, 125mg / tablet, 150mg / tablet,
oral
Arm group label:
SHR-A1811 combined with Dalpiciclib Isethionate Tablets
Intervention type:
Drug
Intervention name:
SHR-A1811 & Fulvestrant
Description:
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intramuscular
Fulvestrant：Injection, 5 ml: 0.25g/bottle, intramuscular
Arm group label:
SHR-A1811 combined with Fulvestrant
Intervention type:
Drug
Intervention name:
SHR-A1811 & Bevacizumab injection
Description:
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Bevacizumab
injection: injection, 100mg / bottle, intravenous drip
Arm group label:
SHR-A1811 combined with Bevacizumab injection
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.
Criteria for eligibility:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
April 2023
Completion date:
February 27, 2025
Lead sponsor:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Jiangsu HengRui Medicine Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05792410
