TST001 in Patients With CLDN18.2 Positive Previously Treated Advanced Biliary Tract Cancer

Biliary Tract Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05190575
• Other study ID #: BTC-II-CLDN18.2-TST001
• Status: Completed
• Phase: Phase 2
• Start date: January 14, 2022
• Est. completion date: May 6, 2023

Study information

• Verified date: December 2021
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 6, 2023
• Est. primary completion date: May 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Tract Neoplasms

Intervention

Drug:
• TST001
TST001 IV infusion every 3 weeks until disease progression or other discontinuation criteria.

Locations

Country	Name	City	State
China	Zhongshan hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Transcenta Holding Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	ORR according to RECIST 1.1 using investigator assessment	18 months
Secondary	PFS	PFS accorridng RECSIST1.1 using investigator assessment	18 months
Secondary	Overall survival	Time from enrollment to death of any cause	18 months
Secondary	DoR	DoR accroding to RECSIST1.1 using investigator assessment	18 months
Secondary	DCR	Patients who were assessed as partial response, complete response or stable disease	18 months
Secondary	Safety & tolerability	Adverse events will be graded according to NCI-CTC AE v5.0	18 months