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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
SHR-A1811:Lyophilized powder injection, 100mg / bottle, intravenous drip Dalpiciclib Isethionate Tablets:Tablet, 25mg / tablet, 50mg / tablet, 125mg / tablet, 150mg / tablet, oral
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
DLT(Phase I (dose-finding phase) main study endpoint)
Time frame: 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)
Time frame: Up to follow-up period, approximately 24 months
Incidence and severity of serious adverse events (SAE)(Phase I (dose-finding phase) main study endpoint)
Time frame: Up to follow-up period, approximately 24 months
Objective response rate(The main end points of the second stage (efficacy expansion stage))
Time frame: Until progression, assessed up to approximately 24 months
SHR-A1811 sparse PK concentrations in serum
Time frame: While on study drug up to study completion, approximately 24 months
Dalpiciclib sparse PK concentrations in plasm
Time frame: While on study drug up to study completion, approximately 24 months
Incidence of anti-drug antibodies (ADA) to SHR-A1811 over time
Time frame: Up to follow-up period, approximately 24 months
Incidence of neutralizing antibody (NAb) to SHR-A1811 over time
Time frame: Up to follow-up period, approximately 24 months
Duration of response (DoR)
Time frame: Until progression or death, assessed up to approximately 24 months
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Progression-free survival (PFS)
Time frame: Until progression or death, assessed up to approximately 24 months