SHR-A1904 for advanced biliary tract cancer after prior systemic treatment failure

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

This trial will test whether the experimental drug SHR-A1904 can help people with advanced or metastatic biliary tract cancer whose prior systemic treatments failed and whose tumors express CLDN18.2.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 151 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (industry)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT07450976 on ClinicalTrials.gov

What this trial studies

This is a multicenter Phase 2 trial enrolling adults with advanced or metastatic biliary tract cancer that is positive for CLDN18.2 and has progressed after prior systemic therapy. Participants receive SHR-A1904 by infusion and continue treatment until unacceptable toxicity or disease progression. The trial is monitoring tumor response by RECIST v1.1, along with safety, pharmacokinetics, and immunogenicity. Sites listed include major cancer centers in Beijing and Shanghai, China.

Who should consider this trial

Good fit: Ideal candidates are adults 18–75 years old with histologically confirmed locally advanced or metastatic biliary tract cancer, ECOG 0–1, CLDN18.2 positive tumors, measurable disease, adequate organ function, and prior systemic therapy failure or intolerance.

Not a fit: Patients without CLDN18.2 expression, with untreated brain metastases, severe liver dysfunction (Child-Pugh C), other active cancers, recent anti-tumor therapy within 4 weeks, or ECOG >1 are unlikely to qualify or benefit from this trial.

Why it matters

Potential benefit: If successful, SHR-A1904 could offer a new targeted treatment option for CLDN18.2-positive biliary tract cancer patients who have exhausted standard systemic therapies.

How similar studies have performed: CLDN18.2-targeted therapies have shown clinical benefit in gastric cancer and early signals in other gastrointestinal tumors, but their use in biliary tract cancer remains investigational with limited published data.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (RECRUITING)
• Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Haoyang Xin

Conditions: Biliary Tract Cancer