Status:
COMPLETED
TST001 in Patients With CLDN18.2 Positive Previously Treated Advanced Biliary Tract Cancer
Lead Sponsor:
Shanghai Zhongshan Hospital
Collaborating Sponsors:
Transcenta Holding Limited
Conditions:
Biliary Tract Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 wit...
Detailed 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 jun...
Eligibility Criteria
Inclusion
- Histologically confirmed, unresectable advanced or metastatic biliary tract cancer.
- Patients failed at least one prior line of systemic medications; if patients had disease progression during or within 6 months after the completion of adjuvant therapy or neoadjuvant therapy, the adjuvant therapy or neoadjuvant therapy could be regarded as one line of therapy.
- CLDN18.2 expression positive confirmed through tumor tissue.
- Patients with at least one measurable disease according to RECISTv1.1.
- ECOG PS of 0 or 1.
- Patients have predicted life expectancy ≥ 12 weeks.
- Paitients with adequate cardica, liver, renal function, etc.
Exclusion
- • History of another concurrent primary malignancy.
- Untreated or symptomatic CNS metastases.
- Prior treatment targeting CLDN18.2.
- Major surgical procedure, prior locoregional therapy such as radioembolization within 28 days prior to the first dose of study drug.
- Prior serious hypersensitivity to monoclonal antibody or any component of the investigational drug.
- Patients had any of the following within 6 months prior to first dose of study treatment: cerebrovascular accident, transient ischemic attack, myocardial infarction or unstable angina pectoris, heart failure NYHA III or IV degree, or uncontolled uarrhythmia requiring intervention.
- Patients who are pregnant or lactating.
Key Trial Info
Start Date :
January 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05190575
Start Date
January 14 2022
End Date
May 6 2023
Last Update
July 27 2023
Active Locations (1)
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1
Zhongshan hospital
Shanghai, China, 200032