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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-A1811 combined with Dalpiciclib Isethionate Tablets | Experimental |
| |
| SHR-A1811 combined with Fulvestrant | Experimental |
| |
| SHR-A1811 combined with Bevacizumab injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1811 & Dalpiciclib Isethionate Tablets | Drug | SHR-A1811:Lyophilized powder injection, 100mg / bottle, intravenous drip Dalpiciclib Isethionate Tablets:Tablet, 25mg / tablet, 50mg / tablet, 125mg / tablet, 150mg / tablet, oral |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| SHR-A1811 sparse PK concentrations in serum | While on study drug up to study completion, approximately 24 months | |
| Dalpiciclib sparse PK concentrations in plasm | While on study drug up to study completion, approximately 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuchao Wu | Contact | +0518-81220121 | shuchao.wu@hengrui.com.cn |
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An open, multicenter, dose-finding and dose expansion investigational Phase IB/II clinical trial
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| SHR-A1811 & Fulvestrant | Drug | SHR-A1811:Lyophilized powder injection, 100mg / bottle, intramuscular Fulvestrant:Injection, 5 ml: 0.25g/bottle, intramuscular |
|
| SHR-A1811 & Bevacizumab injection | Drug | SHR-A1811:Lyophilized powder injection, 100mg / bottle, intravenous drip Bevacizumab injection: injection, 100mg / bottle, intravenous drip |
|
| 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 |
| Duration of response (DoR) | Until progression or death, assessed up to approximately 24 months |
| Progression-free survival (PFS) | Until progression or death, assessed up to approximately 24 months |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077267 | Fulvestrant |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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