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New treatment option for Biliary Tract Cancer
Official title A Study of TQB2102 for Injection in the Treatment of HER2-positive Biliary Tract Cancer
ClinicalTrials.gov ID: NCT06431490
What this study is testing
What is TQB2102 for injection?
TQB2102 for injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for biliary tract cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the efficacy and safety TQB2102 for injection in the treatment of patients with Her2-positive biliary tract cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 18 years ≤ age ≤75 years; Eastern Cooperative Oncology Group (ECOG) score 0 to 1;
- people must provide sufficient tumor tissue sample and confirm HER2 positivity by central laboratory prior to first dose, defined as...
- The main organs function well;
- Meet the criteria for advanced biliary tract cancer:
- Biliary tract carcinoma confirmed by histology or cytology;
You likely can't join if
- Complicated diseases and medical history:
- Have had or are currently suffering from other malignant tumors within 3 years before the first medication;
- Unmitigated toxic effects higher than grade 1 of Common Terminology Criteria for Adverse Events (CTCAE) due to any previous treatment;
- Major surgical treatment, significant traumatic injury, or long-term unhealed wounds or fractures have been received within 4 weeks prior to initial...
- Patients with any bleeding or bleeding events ≥CTCAE grade 3 within 4 weeks before the first dose; Aortic/venous thrombosis events, such as...
- Active viral hepatitis with poor control;
See the full eligibility criteria
- 18 years ≤ age ≤75 years; Eastern Cooperative Oncology Group (ECOG) score 0 to 1;
- people must provide sufficient tumor tissue sample and confirm HER2 positivity by central laboratory prior to first dose, defined as immunohistochemistry (IHC) 3+ or IHC 2+ with in situ hybridization (ISH) positive;
- The main organs function well;
- Meet the criteria for advanced biliary tract cancer:
- Biliary tract carcinoma confirmed by histology or cytology;
- Non-operable locally advanced, recurrent and/or metastatic disease with at least one measurable lesion according to Evaluation criteria for the how well it works of solid tumors (RECIST) 1.1 criteria;
- Failure of 1-2 prior lines of systemic therapy
- 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...
- The people voluntarily joined the study, signed the informed consent, and the compliance was good.
- Complicated diseases and medical history:
- Have had or are currently suffering from other malignant tumors within 3 years before the first medication;
- Unmitigated toxic effects higher than grade 1 of Common Terminology Criteria for Adverse Events (CTCAE) due to any previous treatment;
- Major surgical treatment, significant traumatic injury, or long-term unhealed wounds or fractures have been received within 4 weeks prior to initial medication;
- 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...
- Active viral hepatitis with poor control;
- 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;
- Have a history of psychotropic drug abuse and can not quit or have mental disorders;
- People who are ready to undergo or have previously received allogeneic bone marrow transplantation or solid organ transplantation;
- Have a history of hepatic encephalopathy;
- 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;
- people with any severe and/or uncontrolled disease.
- Tumor related and treatment:
- For people 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...
- 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;
- 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...
- Uncontrolled pleural effusion, pericardial effusion or moderate to severe ascites that still require repeated drainage;
- Obvious biliary obstruction (except for total bilirubin ≤ 2× upper limit of normal (ULN) after endoscopic stent placement and percutaneous transhepatic biliary drainage);
- Known spinal cord compression, cancerous meningitis, with symptoms of brain metastases, or symptoms controlled for less than 4 weeks.
- Research treatment related:
- Known allergy to study drug excipients;
- Have previously received anti-HER2 therapy drugs (only for the second stage, the first stage is not limited);
- 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...
- Participants who participated in and used other anti-tumor clinical trials within 4 weeks before the first medication.
- According to the judgment of the researcher, there is a situation that seriously endangers the safety of the people or affects the completion of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Fuyang, Anhui, China
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Lanzhou, Gansu, China
- Guangzhou, Guangdong, China
- Jiangmen, Guangdong, China
- Nanning, Guangxi, China
- Guiyang, Guizhou, China
- Tangshan, Hebei, China
- Harbin, Heilongjiang, China
- Anyang, Henan, China
- Luoyang, Henan, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Yichang, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Yancheng, Jiangsu, China
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuyang, Anhui, China; Hefei, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Lanzhou, Gansu, China and 25 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.