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

Phase 2

Recruiting

• Conditions: HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
• Interventions: Drug: SHR-A1811; Drug: SHR-1316; Drug: SHR-8068

• Registration Number: NCT06778031
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-01-10
• Study First Posted: 2025-01-16
• Study Start: 2025-02-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-06
• Primary Completion: 2028-06
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The SHR-A1811 combination group	SHR-A1811	-
The SHR-A1811 combination group	SHR-1316	-
The SHR-A1811 combination group	SHR-8068	-

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR) of the SHR-A1811 combination evaluated by investigators	Screening up to study completion, an average of 3 year.

Secondary Outcome Measures

Name	Time	Method
Duration of response (DoR) of the SHR-A1811 combination evaluated by investigators	Screening up to study completion, an average of 3 year.
Disease control rate (DCR) of the SHR-A1811 combination evaluated by investigators	Screening up to study completion, an average of 3 year.
Progression free survival (PFS) of the SHR-A1811 combination evaluated by investigators	Screening up to study completion, an average of 3 year.
Overall survival (OS) of the SHR-A1811 combination evaluated by investigators	Screening up to study completion, an average of 3 year.
Adverse events (AEs)	Screening up to study completion, an average of 3 year.

Trial Locations

Locations (2)

Affiliated Cancer Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China