To evaluate the efficacy and safety TQB2102 for injection in the treatment of patients with Her2-positive biliary tract cancer.
18 years ≤ age ≤75 years; Eastern Cooperative Oncology Group (ECOG) score 0 to 1;
Subjects 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;
Biliary tract carcinoma confirmed by histology or cytology;
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 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;
Single group
TQB2102 for injection
DrugTQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)
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).
Phase II Recommended Dose (RP2D)
Phase II Recommended Dose (RP2D)
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.
Progression-free survival (PFS)
The time between first medication and first disease progression or death from any cause.
Disease control rate (DCR)
The first assessment was complete response, partial response, and time to disease stabilization.
Disease response time (DOR)
First assessed as complete or partial response to first disease progression or time of death from all causes.
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