Back to resultsTST001 in Patients With CLDN18.2 Positive Previously Treated Advanced Biliary Tract Cancer
Primary Purpose
Biliary Tract Neoplasms
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TST001
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Tract Neoplasms
Eligibility Criteria
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.
Sites / Locations
- Zhongshan hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TST001
Arm Description
Drug: TST001 IV infusion every 3 weeks until disease progression or other discontinuation criteria.
Outcomes
Primary Outcome Measures
ORR
ORR according to RECIST 1.1 using investigator assessment
Secondary Outcome Measures
PFS
PFS accorridng RECSIST1.1 using investigator assessment
Overall survival
Time from enrollment to death of any cause
DoR
DoR accroding to RECSIST1.1 using investigator assessment
DCR
Patients who were assessed as partial response, complete response or stable disease
Safety & tolerability
Adverse events will be graded according to NCI-CTC AE v5.0
Full Information
NCT ID
NCT05190575
First Posted
December 28, 2021
Last Updated
July 25, 2023
Sponsor
Shanghai Zhongshan Hospital
Collaborators
Transcenta Holding Limited
1. Study Identification
Unique Protocol Identification Number
NCT05190575
Brief Title
TST001 in Patients With CLDN18.2 Positive Previously Treated Advanced Biliary Tract Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 14, 2022 (Actual)
Primary Completion Date
May 6, 2023 (Actual)
Study Completion Date
May 6, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital
Collaborators
Transcenta Holding Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 with CLDN18.2 positive previously treated unresectable advanced or metastatic Biliary Tract Cancer.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TST001
Arm Type
Experimental
Arm Description
Drug: TST001 IV infusion every 3 weeks until disease progression or other discontinuation criteria.
Intervention Type
Drug
Intervention Name(s)
TST001
Intervention Description
TST001 IV infusion every 3 weeks until disease progression or other discontinuation criteria.
Primary Outcome Measure Information:
Title
ORR
Description
ORR according to RECIST 1.1 using investigator assessment
Time Frame
18 months
Secondary Outcome Measure Information:
Title
PFS
Description
PFS accorridng RECSIST1.1 using investigator assessment
Time Frame
18 months
Title
Overall survival
Description
Time from enrollment to death of any cause
Time Frame
18 months
Title
DoR
Description
DoR accroding to RECSIST1.1 using investigator assessment
Time Frame
18 months
Title
DCR
Description
Patients who were assessed as partial response, complete response or stable disease
Time Frame
18 months
Title
Safety & tolerability
Description
Adverse events will be graded according to NCI-CTC AE v5.0
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia Fan
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan hospital
City
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
TST001 in Patients With CLDN18.2 Positive Previously Treated Advanced Biliary Tract Cancer
We'll reach out to this number within 24 hrs