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

NCT06413745 | Active Not Recruiting Phase 2

• 1 other identifier: SHR-A1811-212
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• ORR evaluated by IRC according to RECIST v1.1 standard

  About a year

Secondary Outcomes (10)

• 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

Study Arms (1)

SHR-A1811

EXPERIMENTAL

Drug: SHR-A1811

Interventions

SHR-A1811 DRUG

SHR-A1811

SHR-A1811

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years old ( including both ends ), male or female ;
• ECOG-PS score : 0 or 1;
• Expected survival ≥ 12 weeks;
• Subjects with locally advanced or recurrent metastatic biliary tract cancer diagnosed by histopathology or cytology are not suitable for surgical resection, transplantation or ablation;
• Subjects who failed or intolerance after systemic chemotherapies;
• According to the RECIST v1.1 standard, the subjects had at least one measurable lesion；
• The main organ function is normal, in line with the program requirements ;
• If the patient has active hepatitis B virus ( HBV ) infection : HBV-DNA must be \< 500 IU / mL；
• Consent to contraception.

You may not qualify if:

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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Zhongshan Hospital，Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 14, 2024
• Study Start: June 4, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

CN (1)