AiZeLi (retlirafusp alfa) / Jiangsu Hengrui Pharma, Dong-A - LARVOL DELTA

Phase II Study of Trastuzumab Rezetecan Combined With Retlirafusp Alfa With or Without CAPOX as Perioperative Therapy for Resectable Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New P2 trial • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

Retlirafusp alfa Combined with Rivoceranib, With or Without Zeprumetostat, in Patients with Advanced Gastric Cancer Who Have Failed First-Line Immunotherapy (ESMO 2026) - No abstract available

Clinical • Metastases • Gastric Cancer • Oncology • Solid Tumor

Phase III study of SHR-1701 versus placebo in combination with chemo as first-line (1L) therapy for HER2-negative gastric/gastroesophageal junction adenocarcinoma (G/GEJA) (ESMO 2024) - P3 | "1L SHR-1701 plus CAPOX showed a statistically significant and clinically meaningful benefit in OS compared with placebo plus CAPOX in pts with HER2-negative G/GEJA, both in PD-L1 CPS ≥5 population and in overall population regardless of PD-L1 level, presenting as a new treatment option."

Clinical • Combination therapy • Late-breaking abstract • P3 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • HER-2 • TGFB1

Retlirafusp Alfa Combined With Famitinib, Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Unresectable Pancreatic Cancer (clinicaltrials.gov) - P2 | N=88 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Zhengzhou University

New P2 trial • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Retlirafusp Alfa Plus Targeted Therapy and Chemotherapy for Unresectable Colorectal Liver-Limited Metastases (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Peking University Cancer Hospital & Institute

New P2 trial • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Solid Tumor • BRAF

Gemcitabine and Albumin-Bound Paclitaxel Combined With Liposomal Irenotecan (II) With or Without SHR-1701 as Neoadjuvant Therapy for Resectable or Borderline Resectable Pancreatic Cancer (clinicaltrials.gov) - P2 | N=62 | Active, not recruiting | Sponsor: The First Hospital of Jilin University

New P2 trial • Oncology • Pancreatic Cancer • Solid Tumor

A Prospective, Randomized, Controlled Phase II Study of Stereotactic Body Radiotherapy (SBRT) Plus SHR-1701 Versus SBRT Alone in Asymptomatic or Mildly Symptomatic Patients with Metastatic Castration-Resistant Prostate Cancer (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A prospective, exploratory study of Retlirafusp alfa combined with FLOT as neoadjuvant therapy for patients with resectable adenocarcinoma of the esophagogastric junction (ChiCTR) - P2 | N=37 | Not yet recruiting | Sponsor: Xijing Hospital, Air Force Medical University; Xijing Hospital, Air Force Medical University

New P2 trial • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • HER-2 • PD-L1

Effect of SHR-1701 on chemotherapy (chemo)-induced myelosuppression: Data from a phase 3 study in HER2-negative gastric/gastroesophageal junction adenocarcinoma (G/GEJA). (ASCO-GI 2025) - P3 | "SHR-1701 showed the capacity to suppress chemo-associated myelosuppression. Safety."

P3 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2 • TGFB1

GnP Combined With SHR-1701 and Apatinib as First-Line Treatment for Locally Advanced or Metastatic PDAC (clinicaltrials.gov) - P1/2 | N=45 | Not yet recruiting | Sponsor: West China Hospital

New P1/2 trial • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

A Single-Arm, Phase II Study of Retlirafusp Alfa in Combination With XELOX and Bevacizumab for the First-Line Treatment of Advanced RAS-Mutated Colorectal Cancer With Liver Metastases (CRLM) (clinicaltrials.gov) - P2 | N=46 | Not yet recruiting | Sponsor: Dai, Guanghai

IO biomarker • New P2 trial • Colorectal Cancer • Oncology • Solid Tumor • RAS

SHR-1701 combined with fuzuloparib and chemotherapy as first-line therapy for advanced lung squamous cell carcinoma: Efficacy and safety results from a phase II study. (ASCO 2026) - P2 | "SHR-1701 plus fuzuloparib and chemotherapy as first-line therapy demonstrated promising anti-tumor activity and a manageable safety profile in patients with advanced LUSC."

Clinical • IO biomarker • Metastases • P2 data • Hematological Disorders • Non Small Cell Lung Cancer • Oncology • Renal Disease • TGFB1

Trastuzumab Combined With Retlirafusp Alfa in Treating HER2（Human Epidermal Growth Factor Receptor 2） 2+/3+ Gastric/Gastroesophageal Junction Adenocarcinoma After First-line Systemic Therapy Failure (clinicaltrials.gov) - P2 | N=35 | Not yet recruiting | Sponsor: Henan Cancer Hospital

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

Neoadjuvant SHR-1701 with or without chemotherapy in unresectable stage III non-small-cell lung cancer: A proof-of-concept, phase 2 trial. (PubMed, Cancer Cell) - "Neoadjuvant SHR-1701 with chemotherapy, followed by surgery or radiotherapy, showed promising efficacy with a tolerable safety profile in unresectable stage III NSCLC. Surgical conversion was feasible in a notable proportion of patients and associated with better survival outcomes."

Journal • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

SHR-1701 Plus Apatinib for Second-Line Treatment in Targeted-Immune Pretreated Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

New P2 trial • Hepatocellular Cancer • Oncology • Solid Tumor

Retlirafusp Alfa Combined With Chemotherapy or Fuzuloparib for Triple-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Harbin Medical University

New P2 trial • Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA1 • BRCA2 • ER • HER-2 • PGR

An Exploratory Clinical Study of Accurate Efficacy Assessment of Neoadjuvant Immunotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma Based on 68Ga-FAPI ([68Ga] Fibroblast Activation Protein Inhibitor)/?F-FDG (2-Deoxy-2-[?F]Fluoro-D-glucose) Dual Imaging (clinicaltrials.gov) - P2 | N=92 | Not yet recruiting | Sponsor: Tan Lijie

New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Retlirafusp Alfa Combined With Chemoradiotherapy in Unresectable ESCC (clinicaltrials.gov) - P=N/A | N=68 | Not yet recruiting | Sponsor: RenJi Hospital

New trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Retlirafusp Alfa Plus Apatinib and Chemotherapy as Second-Line Treatment for Pancreatic Cancer (clinicaltrials.gov) - P2 | N=37 | Not yet recruiting | Sponsor: Tang-Du Hospital

New P2 trial • Oncology • Pancreatic Cancer • Solid Tumor

Efficacy and Safety of Retlirafusp Alfa Plus Bevacizumab and Chemotherapy With or Without Short-Course Radiotherapy in Patients With CRCLM (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

New P2 trial • Colorectal Cancer • Oncology • Solid Tumor

Retlirafusp Alfa Injection Plus Chemotherapy Versus Investigator's Choice of Anti-PD-1 Antibody Plus Chemotherapy as First-line Treatment for Advanced Gastric Cancer With Liver Metastases (clinicaltrials.gov) - P3 | N=332 | Not yet recruiting | Sponsor: Peking University

New P3 trial • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Breaking immune exclusion in cold tumors via TGF-β pathway inhibition. (PubMed, Expert Opin Biol Ther) - "It systematically analyzes preclinical and clinical evidence on bifunctional fusion proteins, represented by M7824 and SHR-1701, as well as bispecific antibodies. The success of TGF-β-targeted therapy depends on moving beyond broad pathway inhibition toward biomarker-guided patient selection and context-dependent intervention. Spatially or biologically restricted targeting, multi-parametric biomarker frameworks, and mechanism-driven combination regimens are likely to define the next phase of clinical development in this field."

IO biomarker • Journal • Oncology • TGFB1

MA-GC-II-026: SHR-1701 Combined With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Ruijin Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Ovarian Cancer • Solid Tumor

A Prospective, Exploratory Study of Retlirafusp Alpha Combined with Chemotherapy as Neoadjuvant Therapy for Patients with Resectable Gastric and Esophagogastric Junction Adenocarcinoma (ChiCTR) - P2 | N=37 | Recruiting | Sponsor: Xijing Hospital, Air Force Medical University; Xijing Hospital, Air Force Medical University

New P2 trial • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • HER-2

Trastuzumab Rezetecan Antibody-Drug Conjugate Combined with Retlirafusp ? in Patients with HER2-Positive and Potentially Immunotherapy-Sensitive Gastric or Gastroesophageal Junction Adenocarcinoma, A Prospective Phase Ib Trial (ChiCTR) - P=N/A | N=12 | Not yet recruiting | Sponsor: Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University); Jiangsu Province Hospital (The First Affiliated Hospital wi

New trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2 • MSI • PD-L1