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

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.

Study Overview

• Status: Completed
• Conditions: Biliary Tract Neoplasms
• Intervention / Treatment: Drug: TST001

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Guoming Shi; Phone Number: +86-13916969578; Email: shi.guoming@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai, China, 200032
    • Zhongshan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TST001; Drug: TST001 IV infusion every 3 weeks until disease progression or other discontinuation criteria.	Drug: TST001; TST001 IV infusion every 3 weeks until disease progression or other discontinuation criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	ORR according to RECIST 1.1 using investigator assessment	18 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Transcenta Holding Limited
• Investigators: Principal Investigator: Jia Fan, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Actual): May 6, 2023
• Study Completion (Actual): May 6, 2023

Study Registration Dates

• First Submitted: December 28, 2021
• First Submitted That Met QC Criteria: December 28, 2021
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Biliary Tract Diseases; Biliary Tract Neoplasms
• Other Study ID Numbers: BTC-II-CLDN18.2-TST001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No