NCT07450976 A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer
| NCT ID | NCT07450976 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Condition | Biliary Tract Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 151 participants |
| Start Date | 2026-03-25 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 151 participants in total. It began in 2026-03-25 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07450976 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Biliary Tract Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07450976 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07450976 currently recruiting?
Yes, NCT07450976 is actively recruiting participants. Contact the research team at haoyang.xin.hx5@hengrui.com for enrollment information.
Where is the NCT07450976 trial being conducted?
This trial is being conducted at Beijing, China, Shanghai, China.
Who is sponsoring the NCT07450976 clinical trial?
NCT07450976 is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. The trial plans to enroll 151 participants.
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