## Protocol Section
### Identification Module
**NCT ID:** NCT06431490

**Brief Title:** A Study of TQB2102 for Injection in the Treatment of HER2-positive Biliary Tract Cancer

**Official Title:** A Study to Evaluate the Efficacy, Safety, and Immunogenicity of TQB2102 for Injection in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer

#### Organization Study ID Info
**ID:** TQB2102-Ib/II-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** To evaluate the efficacy and safety TQB2102 for injection in the treatment of patients with Her2-positive biliary tract cancer.

### Conditions Module

**Conditions:**

- Biliary Tract Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 103

**Type:** ESTIMATED

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, 6/8 cycles.

**Intervention Names:**

- Drug: TQB2102 for injection

**Label:** TQB2102 for injection

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- TQB2102 for injection

**Description:** TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)

**Name:** TQB2102 for injection

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Any adverse medical event that occurred from the time the subject signed the informed consent until 28 days after the last dose/start of the new antitumor therapy (whichever came first).

**Measure:** Incidence and severity of adverse events (AE) and serious adverse events (SAE)

**Time Frame:** From the time the subject signed the informed consent until 28 days after the last dose/start of the new antitumor therapy

**Description:** Phase II Recommended Dose (RP2D)

**Measure:** Phase II Recommended Dose (RP2D)

**Time Frame:** Baseline up to 24 weeks

#### Secondary Outcomes

**Description:** The percentage of subjects achieving complete response (CR) or partial response (PR) as assessed by the investigator based on the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.

**Measure:** Objective response rate (ORR)

**Time Frame:** Baseline up to 36 weeks

**Description:** The time between first medication and first disease progression or death from any cause.

**Measure:** Progression-free survival (PFS)

**Time Frame:** Baseline up to 36 weeks

**Description:** The first assessment was complete response, partial response, and time to disease stabilization.

**Measure:** Disease control rate (DCR)

**Time Frame:** Baseline up to 36 weeks

**Description:** First assessed as complete or partial response to first disease progression or time of death from all causes.

**Measure:** Disease response time (DOR)

**Time Frame:** Baseline up to 36 weeks

**Description:** Time from first use to death from any cause

**Measure:** Overall survival (OS)

**Time Frame:** Baseline up to 36 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 18 years ≤ age ≤75 years; Eastern Cooperative Oncology Group (ECOG) score 0 to 1;
* Test subjects with HER2 expression or amplification or mutation require immunohistochemistry of HER2 3+ or HER2 2 and positive for in situ hybridization (ISH);
* The main organs function well;
* Meet the criteria for advanced biliary tract cancer:

  1. Biliary tract carcinoma confirmed by histology or cytology;
  2. Non-operable locally advanced, recurrent and/or metastatic disease with at least one measurable lesion according to Evaluation criteria for the efficacy of solid tumors (RECIST) 1.1 criteria;
  3. Failure of previous standard treatment.
* Women of reproductive age should agree that effective contraception must be used during the study period and for 6 months after the end of the study, and that serum or urine pregnancy tests are negative within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for 6 months after the end of the study period;
* The subjects voluntarily joined the study, signed the informed consent, and the compliance was good.

Exclusion Criteria:

* Complicated diseases and medical history:

  1. Have had or are currently suffering from other malignant tumors within 3 years before the first medication;
  2. Unmitigated toxic effects higher than grade 1 of Common Terminology Criteria for Adverse Events (CTCAE) due to any previous treatment;
  3. Major surgical treatment, significant traumatic injury, or long-term unhealed wounds or fractures have been received within 4 weeks prior to initial medication;
  4. Patients with any bleeding or bleeding events ≥CTCAE grade 3 within 4 weeks before the first dose; Aortic/venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism, occurred within 6 months prior to initial administration; Treatment with low molecular weight heparin was permitted and antiplatelet drugs were prohibited throughout the study period;
  5. Active viral hepatitis with poor control;
  6. There is a history of active tuberculosis, idiopathic pulmonary fibrosis, institutional pneumonia, drug-induced pneumonia, radiation pneumonia requiring treatment or active pneumonia with clinical symptoms;
  7. Have a history of psychotropic drug abuse and can not quit or have mental disorders;
  8. People who are ready to undergo or have previously received allogeneic bone marrow transplantation or solid organ transplantation;
  9. Have a history of hepatic encephalopathy;
  10. Currently on or recently used (within 7 days before the start of study treatment) aspirin (\>325 mg/ day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel, and cilostazol;
  11. Subjects with any severe and/or uncontrolled disease.
* Tumor related and treatment:

  1. For subjects who have received chemotherapy, immunotherapy within 3 weeks before the first dose, radiation therapy or small molecule targeted drugs within 2 weeks, or who are still within the 5 half-lives of the drug (as the shortest time of occurrence), the washout period is calculated from the end time of the last treatment;
  2. Within 2 weeks before the first use of the drug, the treatment of Chinese patent drugs with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions;
  3. Imaging including computed tomography (CT) or magnetic resonance imaging (MRI) shows that the tumor has invaded important blood vessels, or the investigator determines that the tumor is highly likely to invade important blood vessels during the follow-up study period and cause fatal massive bleeding;
  4. Uncontrolled pleural effusion, pericardial effusion or moderate to severe ascites that still require repeated drainage;
  5. Obvious biliary obstruction (except for total bilirubin ≤ 2× upper limit of normal (ULN) after endoscopic stent placement and percutaneous transhepatic biliary drainage);
  6. Known spinal cord compression, cancerous meningitis, with symptoms of brain metastases, or symptoms controlled for less than 4 weeks.
* Research treatment related:

  1. Known allergy to study drug excipients;
  2. Have previously received anti-HER2 therapy drugs (only for the second stage, the first stage is not limited);
  3. Patients who require immunosuppressive, systemic, or absorbable topical hormone therapy for immunosuppressive purposes and who continue to use it for 7 days prior to initial administration (except for corticosteroids \<10 mg per day of prednisone or other therapeutic hormones).
  4. Participants who participated in and used other anti-tumor clinical trials within 4 weeks before the first medication.
  5. According to the judgment of the researcher, there is a situation that seriously endangers the safety of the subjects or affects the completion 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:** shenfengehbh@sina.com

**Name:** Feng Shen, Doctor

**Phone:** 13901651428

**Role:** CONTACT

**Contact 2:**

**Email:** 13366152815@126.com

**Name:** Jun Zhou, Doctor

**Phone:** 13366152815

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Fuyang

**Contacts:**

***Contact 1:***

- **Email:** qianhesheng@sohu.com

- **Name:** Hesheng Qian, Bachelor

- **Phone:** 13956814015

- **Role:** CONTACT

**Country:** China

**Facility:** Fuyang Cancer Hospital

**State:** Anhui

**Zip:** 236010

**Location 2:**

**City:** Hefei

**Contacts:**

***Contact 1:***

- **Email:** wzg79@zju.edu.cn

- **Name:** Zhanggui Wang, Doctor

- **Phone:** 13637095096

- **Role:** CONTACT

**Country:** China

**Facility:** Anhui Second People's Hospital

**State:** Anhui

**Zip:** 230012

**Location 3:**

**City:** Hefei

**Contacts:**

***Contact 1:***

- **Email:** 834638033@qq.com

- **Name:** Yifu He, Doctor

- **Phone:** 18963789042

- **Role:** CONTACT

**Country:** China

**Facility:** Anhui Provincial Cancer Hospital

**State:** Anhui

**Zip:** 230031

**Location 4:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** hsunyk@126.com

- **Name:** Yongkun Sun, Doctor

- **Phone:** 13141276041

- **Role:** CONTACT

**Country:** China

**Facility:** Cancer Hospital Chinese Academy of Medical Science

**State:** Beijing

**Zip:** 100021

**Location 5:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** 13366152815@126.com

- **Name:** Jun Zhou, Doctor

- **Phone:** 13366152815

- **Role:** CONTACT

**Country:** China

**Facility:** Beijing Cancer Hospital

**State:** Beijing

**Zip:** 100089

**Location 6:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** ymicecream@163.com

- **Name:** Ming Yang, Doctor

- **Phone:** 15810092973

- **Role:** CONTACT

**Country:** China

**Facility:** Tsinghua Changgeng Hospital, Beijing

**State:** Beijing

**Zip:** 100089

**Location 7:**

**City:** Guangzhou

**Country:** China

**Facility:** Sun Yat-sen University Cancer Center

**State:** Guangdong

**Zip:** 510062

**Location 8:**

**City:** Jiangmen

**Contacts:**

***Contact 1:***

- **Email:** gengsheng_yu@hotmail.com

- **Name:** Gengsheng Yu, Doctor

- **Phone:** 13828077428

- **Role:** CONTACT

**Country:** China

**Facility:** Jiangmen Central Hospital

**State:** Guangdong

**Zip:** 529000

**Location 9:**

**City:** Tangshan

**Contacts:**

***Contact 1:***

- **Email:** tcm2000@163.com

- **Name:** Zhiwu Wang, Doctor

- **Phone:** 18931506162

- **Role:** CONTACT

**Country:** China

**Facility:** Tangshan People's Hospital

**State:** Hebei

**Zip:** 063000

**Location 10:**

**City:** Harbin

**Contacts:**

***Contact 1:***

- **Email:** lzhw0451@163.com

- **Name:** Zhiwei Li

- **Phone:** 15004683651

- **Role:** CONTACT

**Country:** China

**Facility:** Harbin Medical University Cancer Hospital

**State:** Heilongjiang

**Zip:** 150081

**Location 11:**

**City:** Zhengzhou

**Contacts:**

***Contact 1:***

- **Email:** yanruqin@163.com

- **Name:** YanRu Qin, Doctor

- **Phone:** 13676932999

- **Role:** CONTACT

**Country:** China

**Facility:** The First Affiliated Hospital of Zhengzhou University

**State:** Henan

**Zip:** 450000

**Location 12:**

**City:** Wuhan

**Contacts:**

***Contact 1:***

- **Email:** Wudajianzhu2004@163.com

- **Name:** Hong Ma, Doctor

- **Phone:** 13377876066

- **Role:** CONTACT

**Country:** China

**Facility:** Huazhong University of Science and Technology

**State:** Hubei

**Zip:** 430023

**Location 13:**

**City:** Wuhan

**Contacts:**

***Contact 1:***

- **Email:** happyzfx@sina.com

- **Name:** Fuxiang Zhou, Doctor

- **Phone:** 18971252780

- **Role:** CONTACT

**Country:** China

**Facility:** Wuhan University Zhongnan Hospital

**State:** Hubei

**Zip:** 430071

**Location 14:**

**City:** Changsha

**Contacts:**

***Contact 1:***

- **Email:** luojia@hnca.org.cn

- **Name:** Jia Luo, Doctor

- **Phone:** 13874994359

- **Role:** CONTACT

**Country:** China

**Facility:** Hunan Cancer Hospital

**State:** Hunan

**Zip:** 410031

**Location 15:**

**City:** Nanjing

**Contacts:**

***Contact 1:***

- **Email:** Xiaofengch198019@126.com

- **Name:** Xiaofeng Chen, Doctor

- **Phone:** 13585172066

- **Role:** CONTACT

**Country:** China

**Facility:** Jiangsu Provincial People's Hospital

**State:** Jiangsu

**Zip:** 210000

**Location 16:**

**City:** Yancheng

**Contacts:**

***Contact 1:***

- **Email:** leeqi2001@hotmail.com

- **Name:** Qi Li, Doctor

- **Phone:** 13818207333

- **Role:** CONTACT

**Country:** China

**Facility:** Dongtai People'S Hospital

**State:** Jiangsu

**Zip:** 224200

**Location 17:**

**City:** Changchun

**Contacts:**

***Contact 1:***

- **Email:** jl.cheng@163.com

- **Name:** Ying Cheng, Doctor

- **Phone:** 0431-85871902

- **Role:** CONTACT

**Country:** China

**Facility:** Jilin Cancer Hospital

**State:** Jilin

**Zip:** 130012

**Location 18:**

**City:** Chifeng

**Contacts:**

***Contact 1:***

- **Email:** M18047660067@163.com

- **Name:** Zhonghua Liu, Doctor

- **Phone:** 18604769266

- **Role:** CONTACT

**Country:** China

**Facility:** Chifeng City Hospital

**State:** Neimengu

**Zip:** 024000

**Location 19:**

**City:** Xi'an

**Contacts:**

***Contact 1:***

- **Email:** ailisuo@mail.xjtu.edu.cn

- **Name:** Aili Suo, Doctor

- **Phone:** 18991232561

- **Role:** CONTACT

**Country:** China

**Facility:** The First Affiliated Hospital of Xi'an Jiaotong University

**State:** Shaanxi

**Zip:** 710000

**Location 20:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Email:** shenfengehbh@sina.com

- **Name:** Feng Shen, Doctor

- **Phone:** 13901651428

- **Role:** CONTACT

***Contact 2:***

- **Email:** annabao212@126.com

- **Name:** Leilei Bao, Doctor

- **Phone:** 021-81875571

- **Role:** CONTACT

**Country:** China

**Facility:** The Third Affiliated Hospital of PLA Navy Medical University

**State:** Shanghai

**Zip:** 200433

**Location 21:**

**City:** Taiyuan

**Contacts:**

***Contact 1:***

- **Email:** wangyusheng1972@163.com

- **Name:** Yusheng Wang, Doctor

- **Phone:** 13834646436

- **Role:** CONTACT

**Country:** China

**Facility:** First Hospital of Shangxi Medical University

**State:** Shanxi

**Zip:** 030001

**Location 22:**

**City:** Tianjin

**Contacts:**

***Contact 1:***

- **Email:** hongli@126.com

- **Name:** Hongli Li, Doctor

- **Phone:** 18622221233

- **Role:** CONTACT

**Country:** China

**Facility:** Tianjin Cancer Hospital

**State:** Tianjin

**Zip:** 300000

## 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: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- 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

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
