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trastuzumab rezetecan (SHR-A1811)
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Other names: SHR-A1811, SHRA1811, SHR A1811
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Company:
Jiangsu Hengrui Pharma
Drug class:
Topoisomerase I inhibitor, HER2-targeted antibody-drug conjugate
Related drugs:
14d
BC-NEO-IIT-SHR-A1811: A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer (clinicaltrials.gov)
P2, N=66, Recruiting, Henan Cancer Hospital | Trial primary completion date: May 2024 --> Dec 2024
Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 expression • HER-2 underexpression
|
trastuzumab rezetecan (SHR-A1811)
1m
Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer (clinicaltrials.gov)
P2, N=120, Recruiting, Fudan University
New P2 trial • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • NECTIN4 (Nectin Cell Adhesion Molecule 4) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
|
HER-2 expression
|
trastuzumab rezetecan (SHR-A1811) • SHR-A2102 • SHR-A1921 • SHR-A2009
1m
SHR-A1811-1316: SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in ER Positive/HER2 Low Breast Cancer (clinicaltrials.gov)
P2, N=93, Recruiting, Shengjing Hospital | Not yet recruiting --> Recruiting | Initiation date: Apr 2024 --> Aug 2024
Enrollment open • Trial initiation date • Combination therapy
|
trastuzumab rezetecan (SHR-A1811) • Ariely (adebrelimab)
2ms
BCTOP-L-M05: SNF Platform Study of HR+/ HER2-advanced Breast Cancer (clinicaltrials.gov)
P2, N=620, Recruiting, Fudan University | N=140 --> 620
Enrollment change
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
ER positive • HR positive • HER-2 amplification • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive • HER-2 negative + PGR positive
|
Avastin (bevacizumab) • sorafenib • everolimus • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • capecitabine • albumin-bound paclitaxel • fulvestrant • exemestane • trastuzumab rezetecan (SHR-A1811) • AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib) • goserelin acetate • famitinib (SHR 1020) • SHR-A2102 • SHR-A1921 • SHR-A2009
2ms
SHR-A1811-I-101: A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov)
P1, N=396, Active, not recruiting, Jiangsu HengRui Medicine Co., Ltd. | Recruiting --> Active, not recruiting | N=226 --> 396 | Trial completion date: Dec 2023 --> Mar 2026 | Trial primary completion date: Dec 2023 --> Dec 2025
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 mutation • HER-2 expression
|
trastuzumab rezetecan (SHR-A1811)
2ms
SHR-A1811-III-301: A Trial of SHR-A1811versus Pyrotinib in Combination With Capecitabine in HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane (clinicaltrials.gov)
P3, N=381, Active, not recruiting, Jiangsu HengRui Medicine Co., Ltd. | Recruiting --> Active, not recruiting | N=269 --> 381 | Trial completion date: Dec 2024 --> Dec 2027 | Trial primary completion date: Dec 2024 --> Dec 2026
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive
|
Herceptin (trastuzumab) • capecitabine • Irene (pyrotinib) • trastuzumab rezetecan (SHR-A1811)
2ms
Neoadjuvant SHR-A1811 Plus Adebrelimab in HR Negative/Low & HER2 Low Breast Cancer Patients (clinicaltrials.gov)
P2, N=60, Not yet recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd.
New P2 trial • Metastases
|
trastuzumab rezetecan (SHR-A1811) • Ariely (adebrelimab)
3ms
Exploratory Platform Research on Precision Therapy of Advanced Pancreatic Cancer (clinicaltrials.gov)
P2, N=120, Not yet recruiting, Fudan University
New P2 trial • Metastases
|
trastuzumab rezetecan (SHR-A1811) • SHR-A2102 • HRS-4642 • SHR-A1904
3ms
FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov)
P2, N=716, Recruiting, Fudan University | Phase classification: P1/2 --> P2
Phase classification
|
HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • FOXC1 (Forkhead Box C1)
|
Herceptin (trastuzumab) • carboplatin • Perjeta (pertuzumab) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Irene (pyrotinib) • albumin-bound paclitaxel • cyclophosphamide • letrozole • epirubicin • trastuzumab rezetecan (SHR-A1811) • AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib) • goserelin acetate • famitinib (SHR 1020) • Ariely (adebrelimab) • SHR-A1921
4ms
SHR-A1811 (antibody-drug conjugate) in advanced HER2-mutant non-small cell lung cancer: a multicenter, open-label, phase 1/2 study. (PubMed, Signal Transduct Target Ther)
The median progression-free survival was 8.4 months (95% CI 7.1-15.0). SHR-A1811 demonstrated favourable safety and clinically meaningful efficacy in pretreated advanced HER2-mutant NSCLC.
P1/2 data • Journal • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
trastuzumab rezetecan (SHR-A1811)
4ms
Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer (clinicaltrials.gov)
P2, N=65, Recruiting, Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting --> Recruiting
Enrollment open • Metastases
|
trastuzumab rezetecan (SHR-A1811)
5ms
A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients (clinicaltrials.gov)
P2, N=65, Recruiting, Shengjing Hospital | Trial completion date: Feb 2029 --> Feb 2030 | Trial primary completion date: Feb 2024 --> Feb 2025
Trial completion date • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2)
|
Irene (pyrotinib) • trastuzumab rezetecan (SHR-A1811)
5ms
Safety, Efficacy, and Pharmacokinetics of SHR-A1811, a Human Epidermal Growth Factor Receptor 2-Directed Antibody-Drug Conjugate, in Human Epidermal Growth Factor Receptor 2-Expressing or Mutated Advanced Solid Tumors: A Global Phase I Trial. (PubMed, J Clin Oncol)
SHR-A1811 exhibited acceptable tolerability, promising antitumor activity, and a favorable pharmacokinetic profile in heavily pretreated advanced solid tumors. The recommended phase II dose of 4.8 or 6.4 mg/kg was selected for various tumor types.
P1 data • PK/PD data • Journal • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
Herceptin (trastuzumab) • trastuzumab rezetecan (SHR-A1811)
5ms
A Study of SHR-A1811 in Subjects With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
P1/2, N=157, Active, not recruiting, Jiangsu HengRui Medicine Co., Ltd. | Recruiting --> Active, not recruiting | Trial completion date: Jan 2024 --> Jun 2025 | Trial primary completion date: May 2023 --> Jun 2025
Enrollment closed • Trial completion date • Trial primary completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
trastuzumab rezetecan (SHR-A1811)
6ms
Study of ADCs Combined With Adebrelimab in HER2-negative Advanced Breast Cancer (clinicaltrials.gov)
P2, N=131, Not yet recruiting, Beijing GoBroad Hospital
New P2 trial • Metastases
|
trastuzumab rezetecan (SHR-A1811) • Ariely (adebrelimab) • SHR-A1921
6ms
A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations (clinicaltrials.gov)
P3, N=300, Not yet recruiting, Jiangsu HengRui Medicine Co., Ltd.
New P3 trial • Metastases
|
cisplatin • carboplatin • paclitaxel • AiRuiKa (camrelizumab) • pemetrexed • trastuzumab rezetecan (SHR-A1811)
6ms
Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer (clinicaltrials.gov)
P2, N=65, Not yet recruiting, Jiangsu HengRui Medicine Co., Ltd.
New P2 trial • Metastases
|
trastuzumab rezetecan (SHR-A1811)
6ms
f SHR-A1811 in Combination With Adebrelimab for the Treatment of HER2 Low-expressing Metastatic Breast Cancer (clinicaltrials.gov)
P2, N=20, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
New P2 trial • Combination therapy • Metastases
|
trastuzumab rezetecan (SHR-A1811) • Ariely (adebrelimab)
8ms
SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in ER Positive/HER2 Low Breast Cancer (clinicaltrials.gov)
P2, N=93, Not yet recruiting, Shengjing Hospital
New P2 trial • Combination therapy
|
trastuzumab rezetecan (SHR-A1811) • Ariely (adebrelimab)
8ms
A Phase 1 Study of SHR-A1811 in Patients With Selected HER2 Expressing Tumors (clinicaltrials.gov)
P1, N=101, Active, not recruiting, Jiangsu HengRui Medicine Co., Ltd. | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Jun 2023 --> Jun 2024
Enrollment closed • Trial completion date • Trial primary completion date • Metastases
|
trastuzumab rezetecan (SHR-A1811)
8ms
A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing (clinicaltrials.gov)
P2, N=88, Recruiting, Fudan University | N=66 --> 88
Enrollment change • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • AR (Androgen receptor)
|
HER-2 positive • HER-2 amplification • HER-2 mutation • AR positive
|
trastuzumab rezetecan (SHR-A1811) • leuprolide acetate for depot suspension • Airui'en (rezvilutamide) • SHR-A1921
8ms
SHR-A1811-309: Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan (clinicaltrials.gov)
P3, N=120, Recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting --> Recruiting
Enrollment open • Metastases
|
Stivarga (regorafenib) • oxaliplatin • irinotecan • Fruzaqla (fruquintinib) • trastuzumab rezetecan (SHR-A1811) • Lonsurf (trifluridine/tipiracil)
10ms
A Trial of SHR-A1811 Combined With Other Antitumor Therapies in Advanced Solid Tumors. (clinicaltrials.gov)
P1/2, N=364, Recruiting, Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting --> Recruiting
Enrollment open
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 expression
|
Irene (pyrotinib) • trastuzumab rezetecan (SHR-A1811)
10ms
Study of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer (clinicaltrials.gov)
P1/2, N=350, Not yet recruiting, Shandong Suncadia Medicine Co., Ltd.
New P1/2 trial • Metastases
|
trastuzumab rezetecan (SHR-A1811) • Ariely (adebrelimab) • SHR-A2009
10ms
SHR-A1811 for Subjects With Her2-positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on or After First-line Anti-HER2 Therapy-containing Regimen (clinicaltrials.gov)
P3, N=360, Recruiting, Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting --> Recruiting
Enrollment open • Metastases
|
HER-2 positive • HER-2 amplification
|
paclitaxel • docetaxel • Cyramza (ramucirumab) • irinotecan • trastuzumab rezetecan (SHR-A1811)
10ms
Injection of SHR-A1811 Versus TAS-102 in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan (clinicaltrials.gov)
P3, N=96, Not yet recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd.
New P3 trial • Metastases
|
oxaliplatin • irinotecan • trastuzumab rezetecan (SHR-A1811) • Lonsurf (trifluridine/tipiracil)
11ms
A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer (clinicaltrials.gov)
P2, N=66, Recruiting, Henan Cancer Hospital | Active, not recruiting --> Recruiting
Enrollment open
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 expression • HER-2 underexpression
|
trastuzumab rezetecan (SHR-A1811)
1year
A Phase III, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy (clinicaltrials.gov)
P3, N=1200, Not yet recruiting, Jiangsu HengRui Medicine Co., Ltd.
New P3 trial
|
Kadcyla (ado-trastuzumab emtansine) • trastuzumab rezetecan (SHR-A1811)
1year
SHR-A1811 for Subjects With Her2-positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on or After First-line Anti-HER2 Therapy-containing Regimen (clinicaltrials.gov)
P3, N=360, Not yet recruiting, Jiangsu HengRui Medicine Co., Ltd.
New P3 trial • Metastases
|
HER-2 positive • HER-2 amplification
|
paclitaxel • docetaxel • Cyramza (ramucirumab) • irinotecan • trastuzumab rezetecan (SHR-A1811)
1year
FUSCC Refractory TNBC Platform Study (FUTURE2.0) (clinicaltrials.gov)
P2, N=120, Recruiting, Fudan University | Not yet recruiting --> Recruiting
Enrollment open
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative • ER negative • PGR negative
|
Avastin (bevacizumab) • AiRuiKa (camrelizumab) • trastuzumab rezetecan (SHR-A1811)
1year
Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases (clinicaltrials.gov)
P2, N=100, Recruiting, Henan Cancer Hospital | N=75 --> 100
Enrollment change • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive
|
Avastin (bevacizumab) • Irene (pyrotinib) • trastuzumab rezetecan (SHR-A1811)
1year
A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
P1/2, N=324, Recruiting, Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy • Metastases
|
Irene (pyrotinib) • trastuzumab rezetecan (SHR-A1811) • Ariely (adebrelimab)
1year
A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer (clinicaltrials.gov)
P3, N=864, Not yet recruiting, Jiangsu HengRui Medicine Co., Ltd.
New P3 trial • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive
|
Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • trastuzumab rezetecan (SHR-A1811)
1year
A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer (clinicaltrials.gov)
P2, N=66, Active, not recruiting, Henan Cancer Hospital | Not yet recruiting --> Active, not recruiting
Enrollment closed
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 expression • HER-2 underexpression
|
trastuzumab rezetecan (SHR-A1811)
over1year
A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing (clinicaltrials.gov)
P2, N=66, Recruiting, Fudan University | Not yet recruiting --> Recruiting | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Sep 2024 --> Sep 2025
Enrollment open • Trial completion date • Trial primary completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • AR (Androgen receptor)
|
HER-2 positive • HER-2 amplification • HER-2 mutation • AR positive
|
trastuzumab rezetecan (SHR-A1811) • leuprolide acetate for depot suspension • Airui'en (rezvilutamide) • SHR-A1921
over1year
A Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression. (clinicaltrials.gov)
P1/2, N=116, Recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting --> Recruiting
Enrollment open • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 expression • HER-2 underexpression
|
capecitabine • trastuzumab rezetecan (SHR-A1811)
over1year
Phase I trial of SHR-A1811 in HER2-expressing advanced gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJ) and colorectal cancer (CRC) (ESMO 2023)
Table: 684P Efficacy outcomes Conclusions SHR-A1811 showed an acceptable safety profile and promising clinical activity in pts with HER2-expressing GC/GEJ and CRC. Further investigation was warranted.
P1 data • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive • HER-2 expression
|
trastuzumab rezetecan (SHR-A1811)
over1year
The HER2-targeting ADC SHR-A1811 in HER2-expressing/mutated advanced non-breast solid tumors (STs): Results from the global phase I study (ESMO 2023)
Background SHR-A1811 is a novel ADC composed of trastuzumab (anti-HER2), a cleavable linker, and a topoisomerase I inhibitor payload, with optimized drug-antibody ratio of 6 and strong bystander killing effect. Table: 656MO ORR by tumor type and HER2 status BTC (N=22) UC (N=23) GC/GEJA (N=13) CRC (N=14) Other tumors (N=26) ORR*, n/N (%)(95% CI) 9/15 (60.0%)(32.3–83.7) 13/22 (59.1%)(36.4–79.3) 6/12 (50.0%)(21.1–78.9) 4/11 (36.4%)(10.9–69.2) 7/25 (28.0%)(12.1–49.4) HER2 IHC 3+ 7/10 (70.0%) (34.8–93.3) 2/6 (33.3%) (4.3–77.7) 4/10 (40.0%) (12.2–73.8) 3/3 (100.0%) (29.2–100.0) 4/8 (50.0%) (15.7–84.3) HER2 IHC 2+ 0/1 7/10 (70.0%) (34.8–93.3) 2/2 (100.0%) (15.8–100.0) 0/3 1/8 (12.5%) (0.3–52.7) HER2 IHC 1+ 1/2 (50.0%) (1.3–98.7) 4/5 (80.0%) (28.4–99.5) 0 0/1 2/6 (33.3%) (4.3–77.7) HER2 mutation and/or amplification 1/2 (50.0%) (1.3–98.7) 0/1 0 1/4 (25.0%) (0.6–80.6) 0/3 *tumor response evaluable set. Conclusions SHR-A1811 had favorable antitumor activity and acceptable safety profile in heavily pretreated HER2-expressing/mutated advanced non-breast STs, including BTC, UC, GC/GEJA, and CRC.
Clinical • P1 data • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive • HER-2 amplification • HER-2 mutation • HER-2 expression
|
Herceptin (trastuzumab) • trastuzumab rezetecan (SHR-A1811)
over1year
SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial (clinicaltrials.gov)
P3, N=530, Recruiting, Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting --> Recruiting
Enrollment open
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 expression
|
gemcitabine • capecitabine • albumin-bound paclitaxel • Halaven (eribulin mesylate) • trastuzumab rezetecan (SHR-A1811)
over1year
A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing (clinicaltrials.gov)
P2, N=66, Not yet recruiting, Fudan University
New P2 trial • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • AR (Androgen receptor)
|
HER-2 positive • HER-2 amplification • HER-2 mutation • AR positive
|
trastuzumab rezetecan (SHR-A1811) • leuprolide acetate for depot suspension • Airui'en (rezvilutamide) • SHR-A1921
over1year
A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer (clinicaltrials.gov)
P2, N=66, Not yet recruiting, Henan Cancer Hospital
New P2 trial
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 expression • HER-2 underexpression
|
trastuzumab rezetecan (SHR-A1811)
over1year
A Study of SHR-A1811 in Subjects With Gynaecologic Oncology (clinicaltrials.gov)
P2, N=225, Not yet recruiting, Jiangsu HengRui Medicine Co., Ltd.
New P2 trial
|
trastuzumab rezetecan (SHR-A1811)
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