Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer

A Phase II Clinical Study of SHR-A1811 in Patients With HER2-expressing/Amplified, Locally Advanced, Unresectable or Metastatic Biliary Tract Cancer (BTC) Who Have Previously Failed First or Second-line Systemic Therapy

This study was to evaluate the efficacy and safety of SHR-A1811 in patients with locally advanced unresectable or recurrent metastatic BTC with HER2 expression / amplification who failed first-line or second-line systemic treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: HER2 Expression / Amplification in Patients With Biliary Tract Cancer
• Intervention / Treatment: Drug: SHR-A1811

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shiwei Sun; Phone Number: +86 18036618554; Email: Shiwei.sun@hengrui.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital,Fudan University
      • Principal Investigator: Jia Fan

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. Subjects with locally advanced or recurrent metastatic biliary tract cancer diagnosed by histopathology or cytology are not suitable for surgical resection, transplantation or ablation;
5. Subjects who failed or intolerance after systemic chemotherapies;
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. If the patient has active hepatitis B virus ( HBV ) infection : HBV-DNA must be < 500 IU / mL；
9. Consent to contraception.

Exclusion Criteria:

1. Received anti-tumor treatment such as chemotherapy, radiotherapy, immunotherapy, biotherapy or other clinical research drugs within 4 weeks before the first administration;
2. Subjects with a history or evidence of brain metastasis or meningeal metastasis ;
3. With acute or chronic uncontrolled pancreatitis or Child-Pugh liver function grade C ;
4. Severe trauma or major surgery was performed within 4 weeks before the first administration;
5. To study the severe heart disease within 6 months before the first administration ;
6. Patients with clinical symptoms and uncontrolled moderate and above pleural effusion, ascites or pericardial effusion, requiring therapeutic puncture drainage ;
7. Severe infection symptoms occurred within 2 weeks before the first administration;
8. Known hereditary or acquired bleeding and thrombotic tendency ;
9. Congenital or acquired immune defects;
10. The subjects had severe and uncontrollable concomitant diseases;
11. Cerebral infarction, pulmonary embolism or deep vein thrombosis occurred within 6 months before the first administration of the study;

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: SHR-A1811	Drug: SHR-A1811; SHR-A1811

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ORR evaluated by IRC according to RECIST v1.1 standard	About a year

Secondary Outcome Measures

Outcome Measure	Time Frame
DoR evaluated by IRC according to RECIST v1.1 standard	About a year
DCR evaluated by IRC according to RECIST v1.1 standard	About a year
PFS evaluated by IRC according to RECIST v1.1 standard	About a year
ORR evaluated by the researchers according to the RECIST v1.1 standard	About a year
DCR evaluated by the researchers according to the RECIST v1.1 standard	About a year
DoR evaluated by the researchers according to the RECIST v1.1 standard	About a year
PFS evaluated by the researchers according to the RECIST v1.1 standard	About a year
OS	About two year
AE	About a year
SAE	About a year

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: May 9, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Biliary Tract Diseases; Biliary Tract Neoplasms
• Other Study ID Numbers: SHR-A1811-212

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