## Protocol Section
### Identification Module
**NCT ID:** NCT06413745

**Brief Title:** 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

#### Organization Study ID Info
**ID:** SHR-A1811-212
#### Organization
**Class:** INDUSTRY
**Full Name:** Jiangsu HengRui Medicine Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2025-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Jiangsu HengRui Medicine Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- HER2 Expression / Amplification in Patients With Biliary Tract Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 65

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: SHR-A1811

**Label:** SHR-A1811

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- SHR-A1811

**Description:** SHR-A1811

**Name:** SHR-A1811

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** ORR evaluated by IRC according to RECIST v1.1 standard

**Time Frame:** About a year

#### Secondary Outcomes

**Measure:** DoR evaluated by IRC according to RECIST v1.1 standard

**Time Frame:** About a year

**Measure:** DCR evaluated by IRC according to RECIST v1.1 standard

**Time Frame:** About a year

**Measure:** PFS evaluated by IRC according to RECIST v1.1 standard

**Time Frame:** About a year

**Measure:** ORR evaluated by the researchers according to the RECIST v1.1 standard

**Time Frame:** About a year

**Measure:** DCR evaluated by the researchers according to the RECIST v1.1 standard

**Time Frame:** About a year

**Measure:** DoR evaluated by the researchers according to the RECIST v1.1 standard

**Time Frame:** About a year

**Measure:** PFS evaluated by the researchers according to the RECIST v1.1 standard

**Time Frame:** About a year

**Measure:** OS

**Time Frame:** About two year

**Measure:** AE

**Time Frame:** About a year

**Measure:** SAE

**Time Frame:** About a year

### Eligibility Module

**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;

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Shiwei.sun@hengrui.com

**Name:** Shiwei Sun

**Phone:** +86 18036618554

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Name:** Jia Fan

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Zhongshan Hospital，Fudan University

**State:** Shanghai

**Zip:** 200032

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001660

- Term: Biliary Tract Diseases

- ID: D000004066

- Term: Digestive System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M4947

- Name: Biliary Tract Neoplasms

- Relevance: HIGH

- As Found: Biliary Tract Cancer

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M4946

- Name: Biliary Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T761

- Name: Biliary Tract Cancer

- Relevance: HIGH

- As Found: Biliary Tract Cancer

### Condition Browse Module - Meshes

- ID: D000001661

- Term: Biliary Tract Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
