Treatment of HER2-positive Biliary Tract Cancer with SHR-A1811

An Open, Multicenter Phase II Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer

This study is testing a new treatment called SHR-A1811 to see if it helps people with advanced HER2-positive biliary tract cancer feel better and live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Harbin, Heilongjiang and 1 other locations)
• Trial ID: NCT06778031 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of SHR-A1811 in combination with other agents for patients with HER2-positive locally advanced or metastatic biliary tract cancer. It is an open, multicenter Phase II trial that includes patients aged 18-75 who have measurable lesions and meet specific health criteria. Participants must not have received systemic antitumor therapy recently and must provide consent for contraception. The study aims to determine how well this treatment works in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with confirmed HER2-positive locally advanced or metastatic biliary tract cancer.

Not a fit: Patients with other active malignancies or those who have received recent local antitumor therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with HER2-positive biliary tract cancer.

How similar studies have performed: Other studies have shown promise in targeting HER2-positive cancers, suggesting potential success for this approach.

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.

Where this trial is running

Harbin, Heilongjiang and 1 other locations

• Affiliated Cancer Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Recruiting)
• Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Tingting Lei, BM

Conditions HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer