NCT06778031 A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
| NCT ID | NCT06778031 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Condition | HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2025-02-26 |
| Primary Completion | 2028-06 |
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 54 participants in total. It began in 2025-02-26 with a primary completion date of 2028-06.
⚠ 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 study is an open, multicenter Phase II clinical trial to evaluate the efficacy and safety of the SHR-A1811 combination in HER2 positive patients with locally advanced or metastatic biliary tract cancer.
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. Subjects who had not previously received any systemic antitumor therapy were allowed to have previously received radical therapy, and had received the last dose of radical therapy for at least 6 months until disease recurrence; 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. Consent to contraception. Exclusion Criteria: 1. Other active malignancies within 5 years or at the same time; 2. Local antitumor therapy was received within 4 weeks prior to initiation of treatment; 3. Subjects with biliary obstruction should be excluded; 4. There is active autoimmune disease or a history of autoimmune disease that may recur; 5. Known or suspected history of interstitial pneumonia or interstitial lung disease, or prior history of interstitial pneumonia or interstitial lung disease requiring hormone therapy; 6. Severe infection within 4 weeks prior to initiation of study treatment; 7. Active hepatitis B virus (HBV) infection; 8. Have serious cardiovascular and cerebrovascular diseases.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06778031 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying HER2-positive Locally Advanced or Metastatic 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 NCT06778031 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 NCT06778031 currently recruiting?
Yes, NCT06778031 is actively recruiting participants. Contact the research team at tingting.lei.tl6@hengrui.com for enrollment information.
Where is the NCT06778031 trial being conducted?
This trial is being conducted at Harbin, China, Shanghai, China.
Who is sponsoring the NCT06778031 clinical trial?
NCT06778031 is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. The trial plans to enroll 54 participants.
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