Clinical Trials Logo

Clinical Trial Summary

TST001 is a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody. This is an open-label, single-arm phase II study to evaluate the efficacy and safety of TST001 for patients with CLDN18.2 positive previously treated unresectable advanced or metastatic Biliary Tract Cancer.


Clinical Trial Description

TST001 is a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody. Claudin18.2 (CLDN18.2) protein is one of the family of tetraspanning proteins expressed at epithelial tight junctions and primarily expressed only in normal gastric tissues . CLDN18.2 protein is a pancancer target expressed in primary lesions and metastases of variouscancer types, including gastric cancer, biliary tract cancer and others. Current available information indicates that CLDN18.2 is a promising therapeutic target for the treatment of solid tumors. This is an open-label, single-arm phase II study to evaluate the efficacy and safety of TST001 for patients with CLDN18.2 positive previously treated unresectable advanced or metastatic Biliary Tract Cancer. Eligible patients will be treated with TST001 until disease progression or other discontinuation criteria met. If there is ≥ one objective response among the first 15 enrolled patients, then the trial continues to enroll a total of 40 patients; if not, then the trial discontinues. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05190575
Study type Interventional
Source Shanghai Zhongshan Hospital
Contact Guoming Shi
Phone +86-13916969578
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date January 30, 2022
Completion date July 30, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT01950572 - Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Active, not recruiting NCT03101566 - Study of Nivolumab in Combination With Gemcitabine/Cisplatin or Ipilimumab for Patients With Advanced Unresectable Biliary Tract Cancer Phase 2
Recruiting NCT04584008 - Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics N/A
Completed NCT00196105 - Malignant Obstruction ZILVER Against Routine Therapy (MOZART I) N/A
Completed NCT02558959 - Second-line Irinotecan and Capecitabine Versus Irinotecan for Gemcitabine and Cisplatin Refractory Biliary Tract Cancer Phase 2
Active, not recruiting NCT02829918 - Study of Nivolumab in Patients With Advanced Refractory Biliary Tract Cancers Phase 2
Recruiting NCT02784353 - Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP Malignancy N/A
Recruiting NCT02255669 - Fully Covered SEMS Versus Partially Covered SEMS With Anti-migration System for Malignant Distal Biliary Obstruction N/A
Completed NCT01731821 - Nonstented Stump-closed vs Duct-to-Mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy Phase 3
Completed NCT00422409 - Endoscopic Stenting of Gastrointestinal Cancer N/A
Terminated NCT02900248 - CureOne Registry: Advanced Malignancy or Myelodysplasia, Tested by Standard Sequencing and Treated by Physician Choice
Recruiting NCT03063554 - EUS BD vs ERCP TP for Pancreatic Cancer N/A
Not yet recruiting NCT02615210 - Mid-Atlantic Research Group Single-Operator Cholangioscopic Assessment of Biliary Strictures N/A
Recruiting NCT04595058 - LAMS Choledochoduodenostomies: With or Without Coaxial Plastic Stent N/A
Recruiting NCT04856761 - A Study of Capecitabine Versus S-1 as Adjuvant Therapy in Patients With Biliary Tract Carcinoma After Surgical Resection
Recruiting NCT03427242 - Apatinib for Advanced Biliary Carcinoma Phase 2
Terminated NCT00359320 - A Randomized Trial of Two Surgical Techniques for Pancreaticojejunostomy in Patients Undergoing Pancreaticoduodenectomy N/A
Completed NCT00980889 - RCT Steel (Wallstent®) vs Nitinol (Wallflex®) Bile Duct Stent for Palliation of Malignant Obstruction Phase 4
Recruiting NCT04308174 - Neoadjuvant Gemcitabine Plus Cisplatin With or Without Durvalumab in Resectable Biliary Tract Cancer Phase 2
Completed NCT01853618 - Tremelimumab With Chemoembolization or Ablation for Liver Cancer Phase 1/Phase 2