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trastuzumab rezetecan (SHR-A1811)
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Other names: SHR-A1811, SHRA1811, SHR A1811, SHR-1811, SHR1811, SHR 1811
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Company:
Glenmark, Jiangsu Hengrui Pharma
Drug class:
Topoisomerase I inhibitor, HER2-targeted antibody-drug conjugate
Related drugs:
5d
Efficacy and Safety of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in Advanced Breast Cancer (clinicaltrials.gov)
P2, N=100, Not yet recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
New P2 trial
|
HER-2 positive
|
Enhertu (fam-trastuzumab deruxtecan-nxki) • trastuzumab rezetecan (SHR-A1811)
6d
Trastuzumab Rezetecan(SHR-A1811) Combined With Ivonescimab (AK112) in Locally Advanced or Metastatic Non-small Cell Lung Cancer Harboring HER2 Gene Abnormalities (clinicaltrials.gov)
P2, N=30, Not yet recruiting, Sun Yat-sen University
New P2 trial
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
|
HER-2 overexpression • HER-2 amplification
|
Herceptin (trastuzumab) • trastuzumab rezetecan (SHR-A1811) • Idafang (ivonescimab)
6d
SHR-A1811-105: Investigation of Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects With HER2-expressing Advanced Breast Cancer (clinicaltrials.gov)
P1, N=17, Completed, Jiangsu HengRui Medicine Co., Ltd. | N=32 --> 17 | Trial completion date: Aug 2026 --> Oct 2025 | Trial primary completion date: Jun 2025 --> Oct 2025 | Recruiting --> Completed
Trial completion • Enrollment change • Trial completion date • Trial primary completion date
|
trastuzumab rezetecan (SHR-A1811) • itraconazole • ritonavir
7d
Trastuzumab Rezetecan and Adebrelimab as Neoadjuvant Therapy for HER2-Positive Muscle-Invasive Bladder Cancer (clinicaltrials.gov)
P2, N=58, Not yet recruiting, Harbin Medical University
New P2 trial
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 expression
|
Herceptin (trastuzumab) • trastuzumab rezetecan (SHR-A1811) • AiRuiLi (adebrelimab)
9d
TAYLOR-002: Efficacy and Safety of Culmerciclib Plus Aromatase Inhibitors in a Response-Adapted Neoadjuvant Strategy for Highly Proliferative ER-Positive/HER2-Negative Breast Cancer (clinicaltrials.gov)
P2, N=45, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University
New P2 trial
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
ER positive • HER-2 negative
|
Herceptin (trastuzumab) • carboplatin • Perjeta (pertuzumab) • Irene (pyrotinib) • albumin-bound paclitaxel • trastuzumab rezetecan (SHR-A1811) • Saitanxin (culmerciclib)
9d
TD-DASHER-01: Neoadjuvant Dalpiciclib + AI → SHR-A1811 for HR+/HER2-Low Breast Cancer (clinicaltrials.gov)
P2, N=20, Not yet recruiting, Tang-Du Hospital
New P2 trial
|
HER-2 (Human epidermal growth factor receptor 2)
|
trastuzumab rezetecan (SHR-A1811) • AiRuiKang (dalpiciclib)
13d
FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov)
P2, N=716, Recruiting, Fudan University | Trial completion date: Sep 2028 --> Sep 2029 | Trial primary completion date: Dec 2026 --> Dec 2027
Trial completion date • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • FOXC1 (Forkhead Box C1)
|
Herceptin (trastuzumab) • carboplatin • Focus V (anlotinib) • Perjeta (pertuzumab) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Irene (pyrotinib) • albumin-bound paclitaxel • cyclophosphamide • letrozole • epirubicin • trastuzumab rezetecan (SHR-A1811) • AiRuiYi (fluzoparib) • Andewei (benmelstobart) • AiRuiKang (dalpiciclib) • goserelin acetate • famitinib (SHR 1020) • Idafang (ivonescimab) • bulumtatug fuvedotin (9MW2821) • AiRuiLi (adebrelimab) • IBI-354 • SHR-4602 • TQB2102 • TQB2868 • anbenitamab repodatecan (JSKN003) • tizetatug rezetecan (SHR-A1921)
21d
Real-world Study of Pyrotinib-containing Regimens of Advanced HER2-positive Breast Cancer (clinicaltrials.gov)
P4, N=500, Not yet recruiting, Peking University People's Hospital
New P4 trial • Real-world evidence
|
HER-2 positive
|
Herceptin (trastuzumab) • Perjeta (pertuzumab) • Irene (pyrotinib) • trastuzumab rezetecan (SHR-A1811)
26d
Trastuzumab Rezetecan (T-DXh) in HER2+ Breast Cancer With Non-pCR After TCbHP (clinicaltrials.gov)
P4, N=59, Not yet recruiting, The First Affiliated Hospital with Nanjing Medical University
New P4 trial
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive
|
Herceptin (trastuzumab) • Perjeta (pertuzumab) • trastuzumab rezetecan (SHR-A1811)
29d
Neoadjuvant SHR-A1811 and SHR-A1701 for Potentially Immunotherapy-Sensitive GC or GEJ Adenocarcinoma (clinicaltrials.gov)
P1, N=12, Not yet recruiting, The First Affiliated Hospital with Nanjing Medical University
New P1 trial
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
|
MSI-H/dMMR
|
Herceptin (trastuzumab) • trastuzumab rezetecan (SHR-A1811) • retlirafusp alfa (SHR-1701)
1m
A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer (clinicaltrials.gov)
P2, N=150, Recruiting, Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting --> Recruiting
Enrollment open
|
Enhertu (fam-trastuzumab deruxtecan-nxki) • trastuzumab rezetecan (SHR-A1811)
1m
Population Pharmacokinetics of Trastuzumab Rezetecan in Patients With HER2-Expressing or Mutated Advanced Solid Tumors. (PubMed, CPT Pharmacometrics Syst Pharmacol)
Based on the covariate analysis, no dose adjustments are warranted for the studied patient population. This model can further support dose selection in future clinical trials through exposure-response analyses.
PK/PD data • Journal
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 mutation • HER-2 expression
|
Herceptin (trastuzumab) • trastuzumab rezetecan (SHR-A1811)
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