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

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.

Study Overview

• Status: Recruiting
• Conditions: HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
• Intervention / Treatment: Drug: SHR-A1811; Drug: SHR-1316; Drug: SHR-8068

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Tingting Lei, BM; Phone Number: +86-18610051325; Email: tingting.lei.tl6@hengrui.com

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Recruiting
      • Affiliated Cancer Hospital of Harbin Medical University
      • Contact: Tongsen Zheng; Phone Number: 15134569619; Email: zhengtongsen@126.com
      • Principal Investigator: Tongsen Zheng
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Principal Investigator: Jian Zhou
      • Contact: Jian Zhou; Phone Number: 021-64041990; Email: zhou.jian@zs-hospital.sh.cn
      • Principal Investigator: Guoming Shi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The SHR-A1811 combination group	Drug: SHR-A1811; SHR-A1811.; Drug: SHR-1316; SHR-1316.; Drug: SHR-8068; SHR-8068.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Biliary Tract Diseases; Biliary Tract Neoplasms
• Other Study ID Numbers: SHR-A1811-215

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No