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

Sponsor

Shanghai Zhongshan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05190575

Collaborator

Transcenta Holding Limited (Other)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Biliary Tract Neoplasms	Drug: TST001	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jan 30, 2022

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Jul 30, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

ORR [18 months]
ORR according to RECIST 1.1 using investigator assessment

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shanghai Zhongshan Hospital
Transcenta Holding Limited

Investigators

Principal Investigator: Jia Fan, Shanghai Zhongshan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Zhongshan Hospital

ClinicalTrials.gov Identifier:

NCT05190575

Other Study ID Numbers:

BTC-II-CLDN18.2-TST001

First Posted:

Jan 13, 2022

Last Update Posted:

Jan 13, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Biliary Tract Neoplasms

Study Results

No Results Posted as of Jan 13, 2022