Drugs / Retlirafusp alfa
last change 11 days ago re-read 8 days ago

Retlirafusp alfa

also known as SHR-1701

Protein / enzyme biologic targets CD274

Developed for
non-small cell lung carcinoma · gastroesophageal junction adenocarcinoma · cancer · colorectal cancer · gastric cancer · esophageal squamous cell carcinoma · gastric adenocarcinoma · gastroesophageal adenocarcinoma
+21 more · gastroesophageal cancer · malignant pancreatic neoplasm · melanoma · nasopharyngeal carcinoma · neoplasm · pancreatic ductal adenocarcinoma · adenocarcinoma · breast cancer · castration-resistant prostate carcinoma · cervical cancer · colorectal adenocarcinoma · head and neck squamous cell carcinoma · hepatocellular carcinoma · Hodgkins lymphoma · intrahepatic cholangiocarcinoma · lung cancer · lymphoma · metastatic malignant neoplasm · ovarian cancer · peritoneal carcinomatosis · rectal cancer
Investigated by
Jiangsu HengRui Medicine Co., Ltd. · Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Fudan University · Henan Cancer Hospital · Tianjin Medical University Cancer Institute and Hospital · Chinese PLA General Hospital
+29 more · Harbin Medical University · Peking University Cancer Hospital & Institute · Tang-Du Hospital · The First Affiliated Hospital of Zhengzhou University · The First Affiliated Hospital with Nanjing Medical University · Atridia Pty Ltd. · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · China Medical University, China · Dai, Guanghai · Hebei Medical University Fourth Hospital · Hong Qiu · Hunan Province Tumor Hospital · Jiangsu Hengrui Pharmaceutical Co., Ltd. · Jingdong Zhang · Nanjing Tianyinshan Hospital · Peking Union Medical College Hospital · Peking University · Qinglei Gao · Shandong Cancer Hospital and Institute · Shanghai Chest Hospital · Shanghai Zhongshan Hospital · Shanxi Province Cancer Hospital · Sun Yat-sen University · The First Hospital of Jilin University · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · West China Hospital · Yong Chen · Zhejiang Cancer Hospital · Zhigang Li

Trials 68 · started per year

today
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2019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 17 trials
Phase 1 NCT07581574 May 2026 → May 2027 expected gastroesophageal adenocarcinoma The First Affiliated Hospital with Nanjing Medical University Not yet recruiting No outcome recorded
Phase 1 NCT05198817 Feb 2022 → Jan 2023 cancer Suzhou Suncadia Biopharmaceuticals Co., Ltd. Unknown No outcome recorded
Phase 1 NCT05048134 Oct 2021 → Feb 2023 cancer Jiangsu HengRui Medicine Co., Ltd. Terminated No outcome recorded Stop: Business
Phase 1 NCT04324814 Mar 2020 → Feb 2023 neoplasm Atridia Pty Ltd. Completed No outcome recorded
Phase 1 NCT04282070 Mar 2020 → Apr 2022 nasopharyngeal carcinoma Jiangsu HengRui Medicine Co., Ltd. Unknown No outcome recorded
Phase 1 NCT03774979 Jan 2019 → Mar 2023 neoplasm Jiangsu HengRui Medicine Co., Ltd. Unknown No outcome recorded
Phase 1 NCT03710265 Nov 2018 → Dec 2022 cancer Jiangsu HengRui Medicine Co., Ltd. Unknown No outcome recorded
Phase 1/28 trials
Phase 1/2 NCT07802184 Sep 2026 → Jan 2029 expected pancreatic ductal adenocarcinoma West China Hospital Not yet recruiting No outcome recorded
Phase 1/2 NCT05896046 Jun 2023 → Jun 2025 Hodgkins lymphoma Chinese PLA General Hospital Unknown No outcome recorded
Phase 1/2 NCT05503888 Oct 2022 → Jul 2027 expected non-small cell lung carcinoma Suzhou Suncadia Biopharmaceuticals Co., Ltd. Not yet recruiting No outcome recorded
Phase 1/2 NCT05020925 Sep 2021 → May 2022 nasopharyngeal carcinoma Jiangsu HengRui Medicine Co., Ltd. Unknown No outcome recorded
Phase 1/2 NCT04856774 Jun 2021 → Mar 2024 cancer Suzhou Suncadia Biopharmaceuticals Co., Ltd. Completed No outcome recorded
Phase 1/2 NCT04679038 Mar 2021 → Dec 2022 cancer Jiangsu HengRui Medicine Co., Ltd. Unknown No outcome recorded
Phase 1/2 NCT04624217 Nov 2020 → Sep 2021 malignant pancreatic neoplasm Jiangsu HengRui Medicine Co., Ltd. Completed No outcome recorded
Phase 1/2 NCT04407741 Sep 2020 → Dec 2024 cancer, lymphoma Chinese PLA General Hospital Unknown No outcome recorded
Phase 244 trials
Phase 2 NCT07797244 Oct 2026 → Apr 2029 expected colorectal cancer Dai, Guanghai Not yet recruiting No outcome recorded
Phase 2 NCT07815288 Sep 2026 → Dec 2029 expected colorectal adenocarcinoma Peking University Cancer Hospital & Institute Not yet recruiting No outcome recorded
Phase 2 NCT07817654 Sep 2026 → Dec 2027 expected — Henan Cancer Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07802288 Sep 2026 → Apr 2029 expected gastroesophageal adenocarcinoma Tianjin Medical University Cancer Institute and Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07814859 Aug 2026 → Aug 2027 expected malignant pancreatic neoplasm The First Affiliated Hospital of Zhengzhou University Not yet recruiting No outcome recorded
Phase 2 NCT07709767 Aug 2026 → Dec 2028 expected gastric adenocarcinoma, gastroesophageal junction adenocarcinoma Tang-Du Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07806110 Jul 2026 → Dec 2027 expected pancreatic ductal adenocarcinoma The First Hospital of Jilin University Active not recruiting No outcome recorded
Phase 2 NCT07728019 Jul 2026 → Jun 2029 expected colorectal cancer Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting No outcome recorded
Phase 2 NCT07709533 Jul 2026 → Jun 2029 expected — Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 2 NCT07689851 Jul 2026 → Jul 2028 expected gastric cancer, gastroesophageal junction adenocarcinoma Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT05149807 Jan 2022 → Apr 2024 gastroesophageal cancer Suzhou Suncadia Biopharmaceuticals Co., Ltd. Terminated No outcome recorded Stop: Business
Phase 2/3 NCT04856787 Jun 2021 → Apr 2024 colorectal cancer Suzhou Suncadia Biopharmaceuticals Co., Ltd. Terminated No outcome recorded Stop: Business
Phase 34 trials
Phase 3 NCT07677293 Jun 2026 → Dec 2028 expected adenocarcinoma Peking University Not yet recruiting No outcome recorded
Phase 3 NCT05179239 Feb 2022 → Aug 2024 cervical cancer Suzhou Suncadia Biopharmaceuticals Co., Ltd. Terminated No outcome recorded Stop: Business
Phase 3 NCT05132413 Dec 2021 → Dec 2024 non-small cell lung carcinoma Suzhou Suncadia Biopharmaceuticals Co., Ltd. Unknown No outcome recorded
Phase 3 NCT04950322 Dec 2021 → May 2024 overdue gastroesophageal cancer Suzhou Suncadia Biopharmaceuticals Co., Ltd. Active not recruiting No outcome recorded
Phase not applicable3 trials
— NCT07855757 Jun 2026 → Jun 2028 expected gastric cancer, peritoneal carcinomatosis Zhejiang Cancer Hospital Active not recruiting No outcome recorded
— NCT07493382 Apr 2026 → Apr 2027 expected gastroesophageal junction adenocarcinoma Tianjin Medical University Cancer Institute and Hospital Not yet recruiting No outcome recorded
— NCT06893887 May 2025 → Dec 2027 expected hepatocellular carcinoma Nanjing Tianyinshan Hospital Recruiting No outcome recorded
Comparator or background therapy2 trials
Phase 2 NCT07845565 Background Nov 2026 → May 2029 expected pancreatic ductal adenocarcinoma Tianjin Medical University Cancer Institute and Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07384234 Background Jan 2026 → Dec 2028 expected gastroesophageal adenocarcinoma Ruijin Hospital Not yet recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2026-07-16 Jiangsu HengRui Medicine Co., Ltd. Results 恒瑞医药创新药瑞拉芙普α用于不可切除Ⅲ期非小细胞肺癌研究成果荣登《自然》子刊STTT hengrui.com ↗
TRAILBLAZER 3年更新数据证实 1 ,七成患者达到3年长期生存。

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 71 sources stand behind the page.

FieldValueCited text
Known as Retlirafusp alfa ClinicalTrials.gov intervention name — accepted as the source's own label NCT07550920 ↗
18

NCT06893887 ↗

NCT07677293 ↗

NCT07618910 ↗

NCT07663071 ↗

NCT07814859 ↗

NCT07802288 ↗

NCT07493382 ↗

NCT07855757 ↗

NCT07709767 ↗

NCT07581574 ↗

Show 8 more sources

Known as SHR-1701 “Stage 1 is a safety lead-in cohort of 6 patients receiving Trastuzumab Rezetecan(SHR-A1811)+Retlirafusp alfa(SHR-1701) plus CAPOX to assess dose-limiting toxicity (DLT) within...” NCT07802288 ↗
53

“A Phase II Study of Neoadjuvant Adebrelimab or Retlirafusp Alfa (SHR-1701) in Combination With Recaticimab and Chemotherapy for Resectable Non-small Cell Lung Cancer” NCT07567326 ↗

“SHR-1701(an Anti-PD-L1/TGF-βRII Fusion Protein)” NCT07845565 ↗

“Retlirafusp alfa (SHR-1701)” NCT07581574 ↗

NCT04884009 ↗

NCT04407741 ↗

NCT05177497 ↗

NCT04856774 ↗

NCT05671822 ↗

NCT07478731 ↗

NCT04355858 ↗

Show 43 more sources

Action Inhibit “Anti-PD-L1/TGFβ fusion protein” NCT04324814 ↗
Modality Protein / enzyme biologic “SHR-1701 is a new bifunctional fusion protein composed of a monoclonal antibody against PD-L1 fused with the extracellular domain of TGF-β receptor II.” PMID 36280870 ↗ Oct 2022
Route Intravenous “Subjects will receive an intravenous infusion of SHR-1701 in a dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.” NCT03710265 ↗
Target CD274 “SHR-1701 is a new bifunctional fusion protein composed of a monoclonal antibody against PD-L1 fused with the extracellular domain of TGF-β receptor II.” PMID 36280870 ↗ Oct 2022