Drugs / Trastuzumab Rezetecan
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Trastuzumab Rezetecan

Monoclonal antibody targets ERBB2

Developed for
breast cancer · HER2 positive breast carcinoma · non-small cell lung carcinoma · female breast carcinoma · hormone receptor-positive breast cancer · triple-negative breast carcinoma · colorectal cancer · gastric cancer
+30 more · breast carcinoma · cancer · gastroesophageal adenocarcinoma · gastroesophageal junction adenocarcinoma · ovarian cancer · biliary tract cancer · biliary tract neoplasm · breast carcinoma by gene expression profile · carcinoma · Her2-receptor negative breast cancer · urothelial carcinoma · bladder urachal carcinoma · colorectal neoplasm · endometrium neoplasm · female reproductive organ cancer · gastric carcinoma · gastric neoplasm · gastroesophageal cancer · head and neck neoplasm · infiltrating bladder urothelial carcinoma · malignant pancreatic neoplasm · metastatic malignant neoplasm in the brain · neoplasm · neoplastic meningitis · ovarian carcinoma · pancreatic neoplasm · progesterone-receptor negative breast cancer · salivary gland carcinoma · urinary bladder carcinoma · uterine cervix neoplasm
Investigated by
Jiangsu HengRui Medicine Co., Ltd. · Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Fudan University · Henan Cancer Hospital · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Peking University Cancer Hospital & Institute
+52 more · Sun Yat-sen University · First Hospital of China Medical University · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Tongji Hospital · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Hebei Medical University Fourth Hospital · Liaoning Cancer Hospital & Institute · Peking Union Medical College Hospital · Shengjing Hospital · Tianjin Medical University Cancer Institute and Hospital · Affiliated Hospital of Nantong University · Atridia Pty Ltd. · Beijing GoBroad Hospital · Beijing Tiantan Hospital · China Medical University, China · Chinese PLA General Hospital · Chongqing University Cancer Hospital · Chuan Wang · First Affiliated Hospital Xi'an Jiaotong University · First Affiliated Hospital of Zhejiang University · Fujian Medical University Union Hospital · Haihua Yuan · Harbin Medical University · Huihua Xiong · Jiangsu Hengrui Pharmaceutical Co., Ltd. · Jilin Provincial Tumor Hospital · Maoming People's Hospital · Nanchang People's Hospital · Ningbo Medical Center Lihuili Hospital · Northern Jiangsu People's Hospital · Peking University People's Hospital · Peking University Shenzhen Hospital · Second Affiliated Hospital, School of Medicine, Zhejiang University · Shandong Suncadia Medicine Co., Ltd. · Shanghai 6th People's Hospital · Shanghai Chest Hospital · Shanghai First Maternity and Infant Hospital · Sheng Tai · Sheng Zhang · Tang-Du Hospital · The First Affiliated Hospital of Guangzhou Medical University · The First Affiliated Hospital of Soochow University · The First Affiliated Hospital with Nanjing Medical University · The First Hospital of Jilin University · The Fourth Affiliated Hospital of China Medical University · The Second Affiliated Hospital of Kunming Medical University · The fifth Affiliated Hospital of Guangzhou Medcial University · Tianjin Medical University Second Hospital · Xijing Hospital · Yongsheng Wang · Yunnan Cancer Hospital · Yunpeng Liu

Trials 100 · started per year

today
1
2
7
14
13
35
28
2021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT07275242 Dec 2025 → Jun 2027 expected cancer Suzhou Suncadia Biopharmaceuticals Co., Ltd. Recruiting No outcome recorded
Phase 1 NCT06710990 Feb → Oct 2025 breast cancer Jiangsu HengRui Medicine Co., Ltd. Completed No outcome recorded
Phase 1 NCT04513223 Mar 2021 → Mar 2025 colorectal cancer, gastric cancer Jiangsu HengRui Medicine Co., Ltd. Completed No outcome recorded
Phase 1 NCT04446260 Sep 2020 → Jun 2025 cancer Jiangsu HengRui Medicine Co., Ltd. Completed No outcome recorded
Phase 1/214 trials
Phase 1/2 NCT07140393 Oct 2025 → Oct 2027 expected neoplasm Jiangsu HengRui Medicine Co., Ltd. Recruiting No outcome recorded
Phase 1/2 NCT07177950 Sep 2025 → Sep 2028 expected breast cancer, metastatic malignant neoplasm in the brain, neoplastic meningitis Peking University Cancer Hospital & Institute Not yet recruiting No outcome recorded
Phase 1/2 NCT06990516 Jun 2025 → Jun 2030 expected ovarian cancer Tongji Hospital Not yet recruiting No outcome recorded
Phase 1/2 NCT06859775 Apr 2025 → Oct 2026 expected Suzhou Suncadia Biopharmaceuticals Co., Ltd. Recruiting No outcome recorded
Phase 1/2 NCT06840002 Mar 2025 → May 2026 overdue ovarian carcinoma Suzhou Suncadia Biopharmaceuticals Co., Ltd. Recruiting No outcome recorded
Phase 1/2 NCT06788197 Mar 2025 → Mar 2028 expected breast cancer Henan Cancer Hospital Not yet recruiting No outcome recorded
Phase 1/2 NCT06718933 Jan 2025 → Aug 2026 overdue breast carcinoma Fudan University Recruiting No outcome recorded
Phase 1/2 NCT06222879 Feb 2024 → Oct 2026 expected breast cancer Shandong Suncadia Medicine Co., Ltd. Recruiting No outcome recorded
Phase 1/2 NCT06015048 Aug 2023 → Nov 2026 expected Jiangsu HengRui Medicine Co., Ltd. Recruiting No outcome recorded
Phase 1/2 NCT05845138 Jul 2023 → Dec 2024 breast cancer Suzhou Suncadia Biopharmaceuticals Co., Ltd. Unknown No outcome recorded
Phase 264 trials
Phase 2 NCT07699952 Jul 2026 → Mar 2029 expected non-small cell lung carcinoma Yongsheng Wang Not yet recruiting No outcome recorded
Phase 2 NCT07630077 Jul 2026 → Jul 2027 expected non-small cell lung carcinoma Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 2 NCT07631884 Jun 2026 → Dec 2028 expected biliary tract neoplasm, colorectal neoplasm, endometrium neoplasm, gastric neoplasm +5 Haihua Yuan Not yet recruiting No outcome recorded
Phase 2 NCT07560475 Jun 2026 → Dec 2028 expected HER2 positive breast carcinoma Tianjin Medical University Cancer Institute and Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07639983 Jun 2026 → Jun 2028 expected infiltrating bladder urothelial carcinoma Sheng Tai Not yet recruiting No outcome recorded
Phase 2 NCT07624201 Jun 2026 → Jun 2028 expected urinary bladder carcinoma Harbin Medical University Not yet recruiting No outcome recorded
Phase 2 NCT07630103 Jun 2026 → Jun 2031 expected breast cancer Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Not yet recruiting No outcome recorded
Phase 2 NCT07618923 Jun 2026 → Jun 2028 expected hormone receptor-positive breast cancer Tang-Du Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07527806 May 2026 → May 2029 expected breast cancer Peking University Cancer Hospital & Institute Not yet recruiting No outcome recorded
Phase 2 NCT07528898 May 2026 → Jul 2027 expected breast cancer Hebei Medical University Fourth Hospital Not yet recruiting No outcome recorded
Phase 315 trials
Phase 3 NCT07676162 Jul 2026 → Sep 2029 expected colorectal cancer Suzhou Suncadia Biopharmaceuticals Co., Ltd. Not yet recruiting No outcome recorded
Phase 3 NCT07679360 Jul 2026 → Dec 2030 expected triple-negative breast carcinoma Suzhou Suncadia Biopharmaceuticals Co., Ltd. Not yet recruiting No outcome recorded
Phase 3 NCT07528716 May 2026 → Dec 2027 expected breast cancer Fudan University Recruiting No outcome recorded
Phase 3 NCT07196774 Oct 2025 → Dec 2027 expected breast carcinoma by gene expression profile Jiangsu HengRui Medicine Co., Ltd. Recruiting No outcome recorded
Phase 3 NCT07111832 Aug 2025 → Mar 2028 expected triple-negative breast carcinoma Suzhou Suncadia Biopharmaceuticals Co., Ltd. Recruiting No outcome recorded
Phase 3 NCT07118527 Aug 2025 → Oct 2030 expected gastroesophageal adenocarcinoma Suzhou Suncadia Biopharmaceuticals Co., Ltd. Recruiting No outcome recorded
Phase 3 NCT06990503 Jun 2025 → Jun 2030 expected ovarian cancer Tongji Hospital Not yet recruiting No outcome recorded
Phase 3 NCT06828354 Mar 2025 → May 2027 expected ovarian cancer Jiangsu HengRui Medicine Co., Ltd. Recruiting No outcome recorded
Phase 3 NCT06430437 Jul 2024 → Feb 2026 overdue non-small cell lung carcinoma Jiangsu HengRui Medicine Co., Ltd. Recruiting No outcome recorded
Phase 3 NCT06199973 Mar 2024 → Apr 2026 overdue colorectal cancer Suzhou Suncadia Biopharmaceuticals Co., Ltd. Active not recruiting No outcome recorded
Phase 42 trials
Phase 4 NCT07600164 Jul 2026 → Dec 2031 expected HER2 positive breast carcinoma Peking University People's Hospital Recruiting No outcome recorded
Phase 4 NCT07589699 May 2026 → Dec 2028 expected HER2 positive breast carcinoma The First Affiliated Hospital with Nanjing Medical University Not yet recruiting No outcome recorded
Phase not applicable1 trial
NCT07377916 Feb 2026 → Jun 2029 expected non-small cell lung carcinoma The First Affiliated Hospital of Guangzhou Medical University Not yet recruiting No outcome recorded
Also used as a comparator or background therapy in 5 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 23 trials
Phase 2 NCT07355764 Comparator Dec 2025 → Jan 2028 expected colorectal cancer Peking Union Medical College Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07100600 Background Aug 2025 → Jul 2030 expected HER2 positive breast carcinoma, metastatic malignant neoplasm in the brain Henan Cancer Hospital Recruiting No outcome recorded
Phase 2 NCT07047443 Background Aug 2025 → Dec 2027 expected breast cancer Anhui Provincial Cancer Hospital Not yet recruiting No outcome recorded
Phase 32 trials
Phase 3 NCT07669610 Comparator Oct 2026 → Sep 2028 expected triple-negative breast carcinoma Fudan University Not yet recruiting No outcome recorded
Phase 3 NCT07382687 Comparator Feb 2026 → Dec 2028 expected breast cancer Fudan University Not yet recruiting No outcome recorded

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 108 sources stand behind the page.

FieldValueCited text
Known as trastuzumab rezetecan “A Randomized, Open-Label, Phase II Study Comparing the Efficacy and Safety of Trastuzumab-rezetecan and Trastuzumab Deruxtecan (T-DXd) in Neoadjuvant Treatment of Patients With...” NCT07416253
24

Trastuzumab rezetecan (also known as SHR-A1811) is a novel antibody-drug conjugate consisting of a humanised HER2-directed monoclonal antibody, cleavable tetrapeptide-based...” PMID 40020696 Feb 2025

Trastuzumab Rezetecan (SHR-A1811) is administered at a dose of 4.8 mg/kg every 21 days (q3w), constituting one treatment cycle.” NCT07309770

“EGFR-TKI combined with Trastuzumab Rezetecan(HER2 ADC)” NCT07699952

NCT07639983

NCT07383818

NCT07624201

NCT07203729

NCT07647263

NCT07600164

NCT07416253

NCT07631884

NCT07630077

NCT07497386

NCT07630103

NCT07100600

NCT07589699

NCT07704177

NCT07670273

NCT07047755

NCT07129018

NCT07037199

NCT07241793

NCT07179939

NCT07679360

Known as ruikang-trastuzumab “SHR-A1811 (ruikang-trastuzumab), a domestically developed ADC by Hengrui Pharmaceutical” NCT07307287
Known as SHR - A1811 “Trastuzumab Rezetecan (SHR-A1811) Versus Chemotherapy of Physician's Choice in Patients With HER2-Low Unresectable/Metastatic Breast Cancer Complicated With Visceral Crisis:A...” NCT07203729
88

“Injection SHR - A1811 (hereinafter referred to as SHR - A1811) is an antibody - drug conjugate (ADC) targeting the HER2 protein” NCT06990503

“SHRA1811(HER-targeted ADC) 4.8 mg/kg, administered via intravenous infusion on Day 1 of each 3-week cycle.” NCT07669610

“Patients with advanced breast cancer expressing HER2 received SHR-A1811 + carboplatin treatment.” NCT07047443

“SHR-A1811 (ruikang-trastuzumab), a domestically developed ADC by Hengrui Pharmaceutical” NCT07307287

“SHR-A1811: 4.8mg/kg given into the vein (IV; intravenously) every 21 days” NCT07527806

“Trastuzumab Rezetecan (SHR-A1811) combined with ivonescimab (AK112)” NCT07630077

“Trastuzumab Rezetecan (SHR-A1811)” NCT07647263

“Drug: SHR- A1811” NCT05896020

NCT07340398

NCT06126640

NCT05824325

NCT05582499

NCT05814354

NCT06718933

NCT06778031

NCT07281209

NCT04446260

NCT07317778

NCT06430437

NCT05671822

NCT07382687

NCT05349409

NCT05353361

NCT07528716

NCT06592625

NCT05594095

NCT05845138

NCT07528898

NCT06199973

NCT07177950

NCT06433609

NCT05076682

NCT06840002

NCT07305246

NCT07417241

NCT06222879

NCT07377916

NCT06123494

NCT06666166

NCT05749588

NCT07309770

NCT06975462

NCT06057610

NCT07140393

NCT06413745

NCT04818333

NCT06361979

NCT05792410

NCT07466927

NCT07102901

NCT05924256

NCT05424835

NCT07129187

NCT07618923

NCT04513223

NCT06340230

NCT06975475

NCT07132242

NCT07051486

NCT06411457

NCT06710990

NCT05911958

NCT07110571

NCT06788197

NCT06859775

NCT06990516

NCT07489703

NCT05769010

NCT06649331

NCT07466303

NCT06881017

NCT06927180

NCT07047443

NCT07111832

NCT07676162

NCT05482568

NCT06828354

NCT06015048

NCT07560475

NCT07355764

NCT05635487

NCT07196774

NCT05896020

NCT07275242

NCT06990503

NCT06547736

NCT07118527

NCT06973525

Known as Trastuzumab Restuzumab “SHR-A1811 (Trastuzumab Restuzumab , an antibody-drug conjugate)” NCT07466303
Action Inhibit “an anti-HER2 antibody-drug conjugate (ADC)” NCT05749588
Modality Monoclonal antibody “an anti-HER2 antibody-drug conjugate (ADC)” NCT05582499
Route Intravenous “SHR-A1811 was administered intravenously at doses ranging from 1.0 to 8.0 mg/kg once every 3 weeks.” PMID 38900984 Jun 2024
Target ERBB2 “antibody-drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2)” PMID 41779980 Mar 2026