A Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Other Therapies in Patients With HER2 Low Advanced or Metastatic Breast Cancer.
- 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.
- Short title
- A Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Other Therapies in Patients With HER2 Low Advanced or Metastatic Breast Cancer.
- Official title
- An Open, Multicenter Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Dalpiciclib, Fulvestrant, Bevacizumab or Letrozole/Anastrozole in Patients With HER2 Low Advanced or Metastatic Breast Cancer.
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Unknown
- Phase
- Phase 1/Phase 2
- Study type
- Interventional
- Completion date
- 2025-02-27
- First posted
- 2023-03-31
- Registry last updated
- 2023-03-31
- Primary completion date
- 2024-02-27
- Start date
- 2023-04-01
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Registry sponsor category
- Industry
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05792410
- ClinicalTrials.gov ID
- NCT05792410
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
DLT(Phase I (dose-finding phase) main study endpoint)
Timeframe: 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)
Timeframe: Up to follow-up period, approximately 24 months
Incidence and severity of serious adverse events (SAE)(Phase I (dose-finding phase) main study endpoint)
Timeframe: Up to follow-up period, approximately 24 months
Objective response rate(The main end points of the second stage (efficacy expansion stage))
Timeframe: Until progression, assessed up to approximately 24 months
SHR-A1811 sparse PK concentrations in serum
Timeframe: While on study drug up to study completion, approximately 24 months
Dalpiciclib sparse PK concentrations in plasm
Timeframe: While on study drug up to study completion, approximately 24 months
Incidence of anti-drug antibodies (ADA) to SHR-A1811 over time
Timeframe: Up to follow-up period, approximately 24 months
Incidence of neutralizing antibody (NAb) to SHR-A1811 over time
Timeframe: Up to follow-up period, approximately 24 months
Duration of response (DoR)
Timeframe: Until progression or death, assessed up to approximately 24 months
Progression-free survival (PFS)
Timeframe: Until progression or death, assessed up to approximately 24 months
- Sex
- Female
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- 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
- 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
Related records
Drugs (4)
Lead sponsors (1)
Conditions (1)
- Breast neoplasm Primary condition