Biliary Tract NeoplasmsPhase 2NCT05190575
TST001 in Patients With CLDN18.2 Positive Previously Treated Advanced Biliary Tract Cancer
A Phase 2 study testing TST001 in people with Biliary Tract Neoplasms, run by Shanghai Zhongshan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Neoplasms
- What is being tested?
- TST001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 14 Jan 2022to 6 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Biliary Tract Neoplasms
- Being tested
- TST001
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TST001Drug
TST001 IV infusion every 3 weeks until disease progression or other discontinuation criteria.
| Study group | Role | What they receive |
|---|---|---|
| TST001 | Experimental | Drug: TST001 IV infusion every 3 weeks until disease progression or other discontinuation criteria. Receives: Drug: TST001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
ORR according to RECIST 1.1 using investigator assessment
Measured: 18 months
Secondary outcomes (5)
PFS
PFS accorridng RECSIST1.1 using investigator assessment
Measured: 18 months
Overall survival
Time from enrollment to death of any cause
Measured: 18 months
DoR
DoR accroding to RECSIST1.1 using investigator assessment
Measured: 18 months
DCR
Patients who were assessed as partial response, complete response or stable disease
Measured: 18 months
Safety & tolerability
Adverse events will be graded according to NCI-CTC AE v5.0
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start14 Jan 2022
- Primary completion6 May 2023
- Study completion6 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract NeoplasmsStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Transcenta Holding Limited
- Responsible party
- Sponsor
- Investigators
- Jia Fan, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190575
- Sponsor's protocol ID
- BTC-II-CLDN18.2-TST001
- Status last verified
- Dec 2021
- First submitted
- 28 Dec 2021
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05190575
- Acronym / sponsor ID
- BTC-II-CLDN18.2-TST001
- Conditions
- Biliary Tract Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Transcenta Holding Limited
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 6 May 2023 (actual)
- Study completion
- 6 May 2023 (actual)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TST001 | Experimental | Drug: TST001Drug: TST001 IV infusion every 3 weeks until disease progression or other discontinuation criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- • History of another concurrent primary malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TST001TST001 IV infusion every 3 weeks until disease progression or other discontinuation criteria. | Drug | TST001 |
Primary outcome
ORR
Time frame: 18 months
ORR according to RECIST 1.1 using investigator assessment
5 secondary outcomes
PFS
Time frame: 18 months
Overall survival
Time frame: 18 months
DoR
Time frame: 18 months
DCR
Time frame: 18 months
Safety & tolerability
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Biliary Tract Neoplasms
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia Fan principal investigator
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TST001 in people with Biliary Tract Neoplasms, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.