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

NCT ID: NCT06413745

Last Updated: 2024-07-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-04
• Study Completion Date: 2025-09-30

Brief Summary

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.

Conditions

HER2 Expression / Amplification in Patients With Biliary Tract Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-A1811

Group Type: EXPERIMENTAL

SHR-A1811

Intervention Type: DRUG

SHR-A1811

Interventions

SHR-A1811

SHR-A1811

Intervention Type: DRUG

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. 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan Hospital，Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shiwei Sun

Role: CONTACT

Shiwei.sun@hengrui.com

+86 18036618554

Other Identifiers

SHR-A1811-212

Identifier Type: -

Identifier Source: org_study_id