Clinical trial NCT06431490: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Biliary Tract Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-28
Enrollment: 103
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: To evaluate the efficacy and safety TQB2102 for injection in the treatment of patients with Her2-positive biliary tract cancer.


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.

Primary outcomes:
measure: Incidence and severity of adverse events (AE) and serious adverse events (SAE)
timeFrame: From the time the subject signed the informed consent until 28 days after the last dose/start of the new antitumor therapy
measure: Phase II Recommended Dose (RP2D)
timeFrame: Baseline up to 24 weeks
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Baseline up to 36 weeks
measure: Progression-free survival (PFS)
timeFrame: Baseline up to 36 weeks
measure: Disease control rate (DCR)
timeFrame: Baseline up to 36 weeks
measure: Disease response time (DOR)
timeFrame: Baseline up to 36 weeks
measure: Overall survival (OS)
timeFrame: Baseline up to 36 weeks
Other outcomes:
Locations:
city: Fuyang
country: China
facility: Fuyang Cancer Hospital
state: Anhui
city: Hefei
country: China
facility: Anhui Second People's Hospital
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
state: Anhui
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Science
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Tsinghua Changgeng Hospital, Beijing
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Jiangmen
country: China
facility: Jiangmen Central Hospital
state: Guangdong
city: Tangshan
country: China
facility: Tangshan People's Hospital
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Wuhan University Zhongnan Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Jiangsu
city: Yancheng
country: China
facility: Dongtai People'S Hospital
state: Jiangsu
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Chifeng
country: China
facility: Chifeng City Hospital
state: Neimengu
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Shanghai
country: China
facility: Shanghai Seventh People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: The Third Affiliated Hospital of PLA Navy Medical University
state: Shanghai
city: Taiyuan
country: China
facility: First Hospital of Shangxi Medical University
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
state: Tianjin
Study officials:
References: