Clinical trial NCT06413745: Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: HER2 Expression / Amplification in Patients With Biliary Tract Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-14
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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;

Primary outcomes:
measure: ORR evaluated by IRC according to RECIST v1.1 standard
timeFrame: About a year
Secondary outcomes:
measure: DoR evaluated by IRC according to RECIST v1.1 standard
timeFrame: About a year
measure: DCR evaluated by IRC according to RECIST v1.1 standard
timeFrame: About a year
measure: PFS evaluated by IRC according to RECIST v1.1 standard
timeFrame: About a year
measure: ORR evaluated by the researchers according to the RECIST v1.1 standard
timeFrame: About a year
measure: DCR evaluated by the researchers according to the RECIST v1.1 standard
timeFrame: About a year
measure: DoR evaluated by the researchers according to the RECIST v1.1 standard
timeFrame: About a year
measure: PFS evaluated by the researchers according to the RECIST v1.1 standard
timeFrame: About a year
measure: OS
timeFrame: About two year
measure: AE
timeFrame: About a year
measure: SAE
timeFrame: About a year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital，Fudan University
state: Shanghai
Study officials:
References: