A Study of TQB2102 for Injection in the Treatment of HER2-positive Biliary Tract Cancer

Biliary Tract Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06431490
• Other study ID #: TQB2102-Ib/II-01
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: July 2024
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Feng Shen, Doctor
• Phone: 13901651428
• Email: shenfengehbh[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 103
• Est. completion date: December 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

Drug:
• TQB2102 for injection
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Science	Beijing	Beijing
China	Tsinghua Changgeng Hospital, Beijing	Beijing	Beijing
China	Jilin Cancer Hospital	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	Chifeng City Hospital	Chifeng	Neimengu
China	Fuyang Cancer Hospital	Fuyang	Anhui
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Anhui Provincial Cancer Hospital	Hefei	Anhui
China	Anhui Second People's Hospital	Hefei	Anhui
China	Jiangmen Central Hospital	Jiangmen	Guangdong
China	Jiangsu Provincial People's Hospital	Nanjing	Jiangsu
China	The Third Affiliated Hospital of PLA Navy Medical University	Shanghai	Shanghai
China	First Hospital of Shangxi Medical University	Taiyuan	Shanxi
China	Tangshan People's Hospital	Tangshan	Hebei
China	Tianjin Cancer Hospital	Tianjin	Tianjin
China	Huazhong University of Science and Technology	Wuhan	Hubei
China	Wuhan University Zhongnan Hospital	Wuhan	Hubei
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Dongtai People'S Hospital	Yancheng	Jiangsu
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events (AE) and serious adverse events (SAE)	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).	From the time the subject signed the informed consent until 28 days after the last dose/start of the new antitumor therapy
Primary	Phase II Recommended Dose (RP2D)	Phase II Recommended Dose (RP2D)	Baseline up to 24 weeks
Secondary	Objective response rate (ORR)	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.	Baseline up to 36 weeks
Secondary	Progression-free survival (PFS)	The time between first medication and first disease progression or death from any cause.	Baseline up to 36 weeks
Secondary	Disease control rate (DCR)	The first assessment was complete response, partial response, and time to disease stabilization.	Baseline up to 36 weeks
Secondary	Disease response time (DOR)	First assessed as complete or partial response to first disease progression or time of death from all causes.	Baseline up to 36 weeks
Secondary	Overall survival (OS)	Time from first use to death from any cause	Baseline up to 36 weeks