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

NCT05190575 | Completed Phase 2

• 1 other identifier: BTC-II-CLDN18.2-TST001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Tract Neoplasms

Outcome Measures

Primary Outcomes (1)

• ORR

  ORR according to RECIST 1.1 using investigator assessment

  18 months

Secondary Outcomes (5)

• PFS

  18 months

• Overall survival

  18 months

• DoR

  18 months

• DCR

  18 months

• Safety & tolerability

  18 months

Study Arms (1)

TST001

EXPERIMENTAL

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

Drug: TST001

Interventions

TST001 DRUG

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

TST001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Transcenta Holding Limited: collaborator

Study Sites (1)

Zhongshan hospital

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Jia Fan

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: January 13, 2022
• Study Start: January 14, 2022
• Primary Completion: May 6, 2023
• Study Completion: May 6, 2023
• Last Updated: July 27, 2023

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)