Clinical trial · Interventional
TST001 in Patients With CLDN18.2 Positive Previously Treated Advanced Biliary Tract Cancer
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
NCT05190575CI-TRIAL-00068280completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TST001 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TST001
- description
- Drug: TST001 IV infusion every 3 weeks until disease progression or other discontinuation criteria.
- interventionNames
- Drug: TST001
Primary outcomes (1)
- measure
- ORR
- timeFrame
- 18 months
- description
- ORR according to RECIST 1.1 using investigator assessment
Secondary outcomes (5)
- measure
- PFS
- timeFrame
- 18 months
- description
- PFS accorridng RECSIST1.1 using investigator assessment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * • 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.
References
Publications (0)
Data not yet available
No reference posted for this study.