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Search / Trial NCT06778031

A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer

Launched by SUZHOU SUNCADIA BIOPHARMACEUTICALS CO., LTD. · Jan 10, 2025

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SHR-A1811 for patients with a specific type of cancer known as HER2-positive locally advanced or metastatic biliary tract cancer. The goal of the study is to find out how effective and safe this treatment is for patients who have this type of cancer. The trial is currently looking for participants aged 18 to 75 years, who are in good health overall and have not received certain previous cancer treatments recently. Eligible participants should have a confirmed diagnosis of biliary tract cancer and at least one measurable tumor.

If you join this trial, you will receive the SHR-A1811 treatment and be monitored closely by doctors to see how your body responds. It's important to note that participants should not have other active cancers or certain serious health conditions, as these may affect the study. By participating, you could help researchers learn more about this treatment and its potential benefits for others with similar cancer.

Gender

ALL

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.

About Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Suzhou Suncadia Biopharmaceuticals Co., Ltd. is a pioneering biopharmaceutical company dedicated to the research, development, and commercialization of innovative therapies to address unmet medical needs. Based in Suzhou, China, the company focuses on advancing novel drug candidates across various therapeutic areas, including oncology and autoimmune diseases. With a commitment to scientific excellence and patient-centric solutions, Suncadia leverages cutting-edge technology and a robust pipeline to improve patient outcomes and contribute to the global healthcare landscape.

Locations

Shanghai, Shanghai, China

Harbin, Heilongjiang, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported