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New antibody TST001 takes on stomach and pancreatic cancers

NCT ID NCT04396821

Disease control Sponsor: Suzhou Transcenta Therapeutics Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests an experimental drug called TST001, an antibody that targets a protein (Claudin 18.2) found on some cancer cells. It is being studied alone or combined with other treatments like nivolumab or chemotherapy in 150 people with advanced stomach, gastroesophageal junction, or pancreatic cancers. The main goals are to check safety, find the best dose, and see how the body handles the drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TST001 (an experimental antibody targeting Claudin 18.2 on cancer cells)
What this could lead to
If successful, this could lead to a new treatment option for advanced stomach, pancreatic, and other solid tumors that have stopped responding to standard therapies.
What could go wrong
This is an early-phase trial focused on safety and dosing, so it is not yet known if TST001 will shrink tumors or improve survival. Side effects from the drug or combinations are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2020

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female ≥ 18 years. * Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors. Part A only: \* Patients must be: a) progressed after standard therapies, b) intolerant of standard therapies, or c) with a tumor type without standard therapy. Part B only: * Cohort A: Patients with previously untreated, unresectable, locally advanced or metastatic GC/GEJ adenocarcinoma; prior adjuvant or neoadjuvant therapy are allowed only if disease progressed or recurred at least 6 months after completion of these treatments. Patients may have received one infusion of mFOLFOX6 plus nivolumab during the screening period. * Cohort B: Patients with GC/GEJ adenocarcinoma who have radiologically progressed following one or two prior systemic therapies; adjuvant or neoadjuvant therapy could be regarded as one line of therapy only if disease progressed or recurred during these treatments or within 6 months or less after completion of these treatments. * Cohort C: Patients with previously untreated, unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma; prior adjuvant or neoadjuvant therapy are allowed only if disease progressed or recurred at least 6 months after completion of these treatments. Patients may have received up to 2 infusions of Gemcitabine + albumin-bound paclitaxel (with one week between each infusion) during the screening period. * Eastern Cooperative Oncology Group Performance Status (ECOG PS): 0-1 . * Patients with adequate cardiac, liver, renal function, etc. Exclusion Criteria * Symptomatic central nervous system metastases. * Prior treatment with any CLDN18.2 target agents * Allergy or sensitivity to TST001 or known allergies to comparable drugs * Documented history of multiple other allergies requiring interventions * Severe cardiovascular disease, including CVA, TIA, myocardial infarction, or unstable angina, NYHA class III or IV heart failure or uncontrolled arrhythmia within 6 months of study entry, severe QTc prolongation, concomitant risks for QTc prolongation. * Concurrent malignancy within 5 years prior to entry except adequately treated certain types of cancer * Active and clinically significant infections, known uncontrolled infections with hepatitis B, hepatitis C, known human immunodeficiency virus with acquired immunodeficiency syndrome related illness * Any condition that the investigator or primary physician believes may not be appropriate for participating in the study. Other protocol-defined Inclusion/Exclusion Criteria could apply. .

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Conditions

The condition(s) this trial relates to.

cancer gastric adenocarcinoma gastric cancer gastric neoplasm gastroesophageal cancer gastroesophageal junction adenocarcinoma malignant pancreatic neoplasm neoplasm pancreatic adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced cancer Gastric cancer Gastroesophageal junction cancer Pancreatic cancer

Contacts and locations

Locations

  • Allegheny Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Banner MD Anderson

    Gilbert, Arizona, 85234, United States

  • Emory University

    Atlanta, Georgia, 30033, United States

  • Florida Cancer Specialists

    Sarasota, Florida, 34232, United States

  • Gabrail Cancer Research

    Canton, Ohio, 44718, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Sloan Kettering

    New York, New York, 10065, United States

  • NEXT Oncology

    Austin, Texas, 78704, United States

  • Pennsylvania Cancer Specialist Research Institute

    Gettysburg, Pennsylvania, 17325, United States

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Stony Brook Cancer Center

    Stony Brook, New York, 11794, United States

  • Swedish Cancer Institute

    Seattle, Washington, 98104, United States

  • University of Arizona

    Tucson, Arizona, 85724, United States

  • University of Kansas, School of Medicine

    Kansas City, Kansas, 66160, United States

  • Vanderbilt University

    Nashville, Tennessee, 37232, United States

  • Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157, United States

  • Washington University

    St Louis, Missouri, 63110, United States

  • Yale University

    New Haven, Connecticut, 06519, United States

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