New targeted therapy aims at Hard-to-Treat bile duct cancers
NCT ID NCT06413745
First seen Jul 17, 2026 · Last updated Jul 17, 2026
Summary
This phase 2 trial tests an experimental drug called SHR-A1811 in people with advanced biliary tract cancer that has HER2 expression or amplification and has stopped responding to earlier treatments. The drug is an antibody-drug conjugate designed to deliver a chemotherapy-like payload directly to HER2-positive cancer cells. The study will measure how many patients' tumors shrink and how long that effect lasts.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental antibody-drug conjugate called SHR-A1811 that targets HER2-positive cancer cells
- What this could lead to
- If successful, this could offer a new treatment option for people with advanced biliary tract cancer whose tumors have HER2 alterations and who have run out of standard therapies.
- What could go wrong
- This is an early-phase trial with only 59 participants, so results may not apply broadly. The drug may cause side effects or fail to shrink tumors in many patients.
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
-
59 people
The number who actually took part.
- Started
-
Jun 2024
- Expected to finish
-
Jul 2027
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
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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 Hide 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. Subjects with locally advanced or recurrent metastatic biliary tract cancer diagnosed by histopathology or cytology are not suitable for surgical resection, transplantation or ablation; 5. Subjects who failed or intolerance after systemic chemotherapies; 6. According to the RECIST v1.1 standard, the subjects had at least one measurable lesion; 7. The main organ function is normal, in line with the program requirements ; 8. If the patient has active hepatitis B virus ( HBV ) infection : HBV-DNA must be \< 500 IU / mL; 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. Subjects with a history or evidence of brain metastasis or meningeal metastasis ; 3. With acute or chronic uncontrolled pancreatitis or Child-Pugh liver function grade C ; 4. Severe trauma or major surgery was performed within 4 weeks before the first administration; 5. To study the severe heart disease within 6 months before the first administration ; 6. Patients with clinical symptoms and uncontrolled moderate and above pleural effusion, ascites or pericardial effusion, requiring therapeutic puncture drainage ; 7. Severe infection symptoms occurred within 2 weeks before the first administration; 8. Known hereditary or acquired bleeding and thrombotic tendency ; 9. Congenital or acquired immune defects; 10. The subjects had severe and uncontrollable concomitant diseases; 11. 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Zhongshan Hospital,Fudan University
Shanghai, Shanghai Municipality, 200032, China