NCT07450976RecruitingPhase 2
A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer
A Phase IIa/IIb Clinical Study of SHR-A1904 in Patients With Previous Systemic Treatment Failure, Positive CLDN18.2 Expression of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer
Source: ClinicalTrials.gov · Last updated 31 Mar 2026
Brief summary (registry, in English)
This is a multicenter, Phase 2 clinical trial to evaluate the efficacy and safety, PK and immunogenicity of SHR-A1904 in patients with advanced or metastatic biliary tract cancer (BTC). Patients will treat with SHR-A1904 until unacceptable toxicity or disease progression.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 151 (estimated)
- First submitted
- 27 Feb 2026
- Start date
- 25 Mar 2026
- Primary completion date
- Dec 2030
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07450976
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 151
- From 25 Mar 2026 to the primary completion date, Dec 2030
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received anti-tumor treatment such as chemotherapy, radiotherapy, immunotherapy, biotherapy or other clinical research drugs within 4 weeks before the first administration;
- Severe trauma or major surgery was performed within 4 weeks before the first administration;
- To study the severe heart disease within 6 months before the first administration;
- Severe infection symptoms occurred within 2 weeks before the first administration;
- The subjects had severe and uncontrollable concomitant diseases;
- Cerebral infarction, pulmonary embolism or deep vein thrombosis occurred within 6 months before the first administration of the study.
Other illness
- Other active malignancies within 5 years or at the same time;
- Known hereditary or acquired bleeding and thrombotic tendency;
Other
- Subjects with a history or evidence of brain metastasis or meningeal metastasis;
- With acute or chronic uncontrolled pancreatitis or Child-Pugh liver function grade C;
- Patients with clinical symptoms and uncontrolled moderate and above pleural effusion, ascites or pericardial effusion, requiring therapeutic puncture drainage;
- Congenital or acquired immune defects;
Who the study is looking for
- Age 18-75 years old (including both ends), male or female;
- ECOG-PS score: 0 or 1;
- Expected survival ≥ 12 weeks;
- Locally advanced or metastatic biliary tract cancer confirmed by histopathology or cytology;
- CLDN18.2 positive expression;
- Subjects who failed or intolerance after systemic chemotherapies;
- According to the RECIST v1.1 standard, the subjects had at least one measurable lesion;
- The main organ function is normal, in line with the program requirements;
- Consent to contraception.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.