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New hope for bile duct cancer: targeted drug SHR-A1904 enters Mid-Stage trial

NCT ID NCT07450976

Disease control Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an experimental drug called SHR-A1904 in people with advanced biliary tract cancer (bile duct cancer) that has not responded to previous treatments. The drug targets a protein called CLDN18.2 found on some cancer cells. The trial aims to see if the drug can shrink tumors and control the disease. About 151 participants will receive the drug until their cancer worsens or side effects become too severe.

What this could mean

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

Active substance
SHR-A1904 (an experimental drug that targets a protein called CLDN18.2 on cancer cells)
What this could lead to
If successful, this could provide a new treatment option for people with advanced biliary tract cancer who have run out of standard therapies.
What could go wrong
This is an early Phase 2 trial with only 151 participants, so results may not apply to everyone. The drug may cause side effects or fail to shrink tumors.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 151 people

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

Started

Mar 2026

Expected to finish

Dec 2030

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 to 75 years

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: 1. Age 18-75 years old (including both ends), male or female; 2. ECOG-PS score: 0 or 1; 3. Expected survival ≥ 12 weeks; 4. Locally advanced or metastatic biliary tract cancer confirmed by histopathology or cytology; 5. CLDN18.2 positive expression; 6. Subjects who failed or intolerance after systemic chemotherapies; 7. According to the RECIST v1.1 standard, the subjects had at least one measurable lesion; 8. The main organ function is normal, in line with the program requirements; 9. Consent to contraception. Exclusion Criteria: 1. Received anti-tumor treatment such as chemotherapy, radiotherapy, immunotherapy, biotherapy or other clinical research drugs within 4 weeks before the first administration; 2. Other active malignancies within 5 years or at the same time; 3. Subjects with a history or evidence of brain metastasis or meningeal metastasis; 4. With acute or chronic uncontrolled pancreatitis or Child-Pugh liver function grade C; 5. Severe trauma or major surgery was performed within 4 weeks before the first administration; 6. To study the severe heart disease within 6 months before the first administration; 7. Patients with clinical symptoms and uncontrolled moderate and above pleural effusion, ascites or pericardial effusion, requiring therapeutic puncture drainage; 8. Severe infection symptoms occurred within 2 weeks before the first administration; 9. Known hereditary or acquired bleeding and thrombotic tendency; 10. Congenital or acquired immune defects; 11. The subjects had severe and uncontrollable concomitant diseases; 12. Cerebral infarction, pulmonary embolism or deep vein thrombosis occurred within 6 months before the first administration of the study.

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Conditions

The condition(s) this trial relates to.

biliary tract cancer Biliary Tract Neoplasms

As listed by the trial registrant

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

Biliary tract cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cancer Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100021, China

  • Zhongshan Hospital, Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

More trials for these conditions

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