A Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Other Therapies in Patients With HER2 Low Advanced or Metastatic Breast Cancer.
Phase 1
Not yet recruiting
- Conditions
- HER2 Low Advanced or Metastatic Breast Cancer
- Interventions
- Registration Number
- NCT05792410
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 300
Inclusion Criteria
- 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
- 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
- ECOG Performance Status of 0 or 1
- Patient must have adequate tumor sample for biomarker assessment
- At least one measurable lesion
- Adequate organ function
Exclusion Criteria
- There are untreated or active central nervous system (CNS) tumor metastases
- 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)
- Major surgery within 4 weeks prior to enrollment
- Has multiple primary malignancies within 5 years, excluding cured basal cell carcinoma of skin, cervical carcinoma in situ, papillary thyroid carcinoma, etc
- Has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out at screening
- Uncontrolled intercurrent illness
- Uncontrolled or significant cardiovascular disease
- Has known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.
- According to NCI-CTCAE v5.0 classification, those who have not recovered to grade Ⅰ toxicity caused by previous anti-tumour treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SHR-A1811 combined with Bevacizumab injection SHR-A1811 & Bevacizumab injection - SHR-A1811 combined with Fulvestrant SHR-A1811 & Fulvestrant - SHR-A1811 combined with Dalpiciclib Isethionate Tablets SHR-A1811 & Dalpiciclib Isethionate Tablets -
- Primary Outcome Measures
Name Time Method Objective response rate(The main end points of the second stage (efficacy expansion stage)) Until progression, assessed up to approximately 24 months DLT(Phase I (dose-finding phase) main study endpoint) At the end of cycle 1(each cycle is 28 days for SHR-A1811+ fulvestrant; each cycle is 21 days for SHR-A1811+other therapies. AE(Phase I (dose-finding phase) main study endpoint) Up to follow-up period, approximately 24 months Incidence and severity of serious adverse events (SAE)(Phase I (dose-finding phase) main study endpoint) Up to follow-up period, approximately 24 months
- Secondary Outcome Measures
Name Time Method SHR-A1811 sparse PK concentrations in serum While on study drug up to study completion, approximately 24 months Progression-free survival (PFS) Until progression or death, assessed up to approximately 24 months Dalpiciclib sparse PK concentrations in plasm While on study drug up to study completion, approximately 24 months Incidence of neutralizing antibody (NAb) to SHR-A1811 over time Up to follow-up period, approximately 24 months Incidence of anti-drug antibodies (ADA) to SHR-A1811 over time Up to follow-up period, approximately 24 months Duration of response (DoR) Until progression or death, assessed up to approximately 24 months