{"entity":{"id":"retlirafusp-alfa","kind":"drug","name":"Retlirafusp alfa","aka":[],"tldr":"Retlirafusp alfa is Hengrui's PD-L1 and TGF-beta bifunctional antibody, in phase 3 trials with chemotherapy in gastric cancer after the Western class leader bintrafusp alfa failed.","summary":"SHR-1701 combines PD-L1 blockade with a TGF-beta trap in a single molecule. Hengrui and Suncadia are running phase 3 trials with capecitabine and oxaliplatin (CAPOX) in first-line advanced gastric and gastro-oesophageal junction cancer, and further studies in cervical and other cancers, after Merck KGaA's bintrafusp alfa was discontinued in 2023 when its lung and biliary trials failed.","status":"phase-3","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov: trials of Retlirafusp alfa","url":"https://clinicaltrials.gov/search?intr=SHR-1701"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["checkpoint-inhibitor","bispecific-antibody"],"targets":["pdl1"],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":["nct04950322","nct07175220","nct05300269","nct07102901","nct05671822"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2, curated)","editedOn":"2026-09-16"},"code":"SHR-1701","modality":"Bifunctional fusion protein (anti-PD-L1 antibody fused to a TGF-beta receptor II trap), intravenous","mechanism":"One arm blocks PD-L1 while the fused receptor domain soaks up TGF-beta in the tumour, attacking two immunosuppressive signals at once; the class was pioneered by bintrafusp alfa.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/retlirafusp-alfa/","neighbours":{"cancer":[{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"}],"technology":[{"id":"bispecific-antibody","kind":"technology","name":"Bispecific antibodies","route":"/technologies/bispecific-antibody/"},{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"pdl1","kind":"target","name":"PD-L1","route":"/targets/pdl1/"}],"company":[{"id":"hengrui","kind":"company","name":"Jiangsu Hengrui Pharmaceuticals","route":"/companies/hengrui/"}],"trial":[{"id":"nct04950322","kind":"trial","name":"A Trial of SHR1701 Plus Chemotherapy in Patients With Gastric or Gastroesophageal Cancer","route":"/trials/nct04950322/"},{"id":"nct07802184","kind":"trial","name":"GnP Combined With SHR-1701 and Apatinib as First-Line Treatment for Locally Advanced or Metastatic PDAC","route":"/trials/nct07802184/"},{"id":"nct05671822","kind":"trial","name":"Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer","route":"/trials/nct05671822/"},{"id":"nct05503888","kind":"trial","name":"Phase Ib/II Study of Almonertinib Combined With SHR-1701 in the Treatment of Relapsed or Advanced Non-small Cell Lung Cancer","route":"/trials/nct05503888/"},{"id":"nct07175220","kind":"trial","name":"Phase II Clinical Study of SHR2554 Tablets Combined With Other Anti-tumor Treatments in Non-small Cell Lung Cancer Subjects","route":"/trials/nct07175220/"},{"id":"nct07752550","kind":"trial","name":"Retlirafusp Alfa Combined With Chemotherapy or Fuzuloparib for Triple-Negative Breast Cancer","route":"/trials/nct07752550/"},{"id":"nct07773363","kind":"trial","name":"Retlirafusp Alfa Plus Apatinib and Chemotherapy as Second-Line Treatment for Pancreatic Cancer","route":"/trials/nct07773363/"},{"id":"nct07102901","kind":"trial","name":"Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma","route":"/trials/nct07102901/"},{"id":"nct06679673","kind":"trial","name":"SHR-1701 Combined with SHR2554 and BP102 for MCRC","route":"/trials/nct06679673/"},{"id":"nct05300269","kind":"trial","name":"SHR-1701 in Combination With Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer","route":"/trials/nct05300269/"},{"id":"nct07503639","kind":"trial","name":"Umbrella Trial of Neoadjuvant Therapy for Locally Advanced Colorectal Cancer","route":"/trials/nct07503639/"}]}}