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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: tingting.lei.tl6@hengrui.com
• Phone: +86-18610051325

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combination therapy for advanced HER2-positive biliary tract cancer

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• SKB264 with inetetamab for HER2-positive advanced breast cancer after progression on T-DXd

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  Recruiting Phase 2 Fudan University · Shanghai · NCT07182721

• Treatment of Her2-positive Biliary Tract or Colorectal Cancer with SPH5030 Tablets

  This study is testing if SPH5030 tablets can help people with advanced Her2-positive biliary tract or colorectal cancer feel better and manage their disease.

  Recruiting at 30 sites Phase 2 Shanghai Pharmaceuticals Holding Co., Ltd · Beijing and 29 other locations · NCT06434597

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.