Clinical trial NCT06778031: A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
Official title: An Open, Multicenter Phase II Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-16
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Objective response rate (ORR) of the SHR-A1811 combination evaluated by investigators
timeFrame: Screening up to study completion, an average of 3 year.
Secondary outcomes:
measure: Duration of response (DoR) of the SHR-A1811 combination evaluated by investigators
timeFrame: Screening up to study completion, an average of 3 year.
measure: Disease control rate (DCR) of the SHR-A1811 combination evaluated by investigators
timeFrame: Screening up to study completion, an average of 3 year.
measure: Progression free survival (PFS) of the SHR-A1811 combination evaluated by investigators
timeFrame: Screening up to study completion, an average of 3 year.
measure: Overall survival (OS) of the SHR-A1811 combination evaluated by investigators
timeFrame: Screening up to study completion, an average of 3 year.
measure: Adverse events (AEs)
timeFrame: Screening up to study completion, an average of 3 year.
Other outcomes:
Locations:
city: Harbin
country: China
facility: Affiliated Cancer Hospital of Harbin Medical University
state: Heilongjiang
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
References: