HER2 Low Advanced or Metastatic Breast Cancer
Conditions
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.
Interventions
DRUGSHR-A1811 & Dalpiciclib Isethionate Tablets
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Dalpiciclib Isethionate Tablets：Tablet, 25mg / tablet, 50mg / tablet, 125mg / tablet, 150mg / tablet, oral
DRUGSHR-A1811 & Fulvestrant
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intramuscular Fulvestrant：Injection, 5 ml: 0.25g/bottle, intramuscular
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Bevacizumab injection: injection, 100mg / bottle, intravenous drip
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
An open, multicenter, dose-finding and dose expansion investigational Phase IB/II clinical trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Objective response rate(The main end points of the second stage (efficacy expansion stage)) | Until progression, assessed up to approximately 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DoR) | Until progression or death, assessed up to approximately 24 months |
| 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 anti-drug antibodies (ADA) to SHR-A1811 over time | Up to follow-up period, approximately 24 months |
| Incidence of neutralizing antibody (NAb) to SHR-A1811 over time | Up to follow-up period, approximately 24 months |
Contacts
Primary ContactShuchao Wu
Outcome results
None listed