RecruitingPhase 2NCT06778031
A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
An Open, Multicenter Phase II Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Enrollment
54 participants
Start Date
Feb 26, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria8
- Age 18-75 years old (including both ends), male or female;
- ECOG-PS score: 0 or 1;
- Expected survival ≥ 12 weeks;
- Locally advanced or metastatic biliary tract cancer confirmed by histopathology or cytology;
- 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;
- According to the RECIST v1.1 standard, the subjects had at least one measurable lesion;
- The main organ function is normal, in line with the program requirements;
- Consent to contraception.
Exclusion Criteria8
- Other active malignancies within 5 years or at the same time;
- Local antitumor therapy was received within 4 weeks prior to initiation of treatment;
- Subjects with biliary obstruction should be excluded;
- There is active autoimmune disease or a history of autoimmune disease that may recur;
- Known or suspected history of interstitial pneumonia or interstitial lung disease, or prior history of interstitial pneumonia or interstitial lung disease requiring hormone therapy;
- Severe infection within 4 weeks prior to initiation of study treatment;
- Active hepatitis B virus (HBV) infection;
- Have serious cardiovascular and cerebrovascular diseases.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGSHR-A1811
SHR-A1811.
DRUGSHR-1316
SHR-1316.
DRUGSHR-8068
SHR-8068.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06778031