A Single-arm, Multicenter, Open-label, Phase II Clinical Study of Vedotin for Injection as Second-line or Later Treatment for Advanced Biliary Tract Cancer.
Sponsor study identifier
interventional
30
1 country
1
Study Start
September 22, 2026
Actual (reported)Primary Completion
September 22, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 22, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Malignant tumors of the biliary system are highly invasive and malignant with an increasing incidence rate. Comprehensive drug therapy is the main treatment for advanced biliary tract tumors, yet the current gemcitabine plus platinum-based chemotherapy regimens yield suboptimal efficacy maintenance in patients with advanced biliary tract tumors. There is an urgent need for effective second-line treatment regimens for advanced biliary tract tumors. Vicinecumab is a recombinant humanized anti-EGFR monoclonal antibody generated by conjugating a potent cytotoxic small molecule to trastuzumab. It inhibits tumor cell proliferation and promotes tumor cell death by blocking various cellular physiological functions including mitosis. Current research data have demonstrated that in patients with recurrent and metastatic nasopharyngeal carcinoma who have received systemic therapy, vicinecumab can significantly improve patients' survival and prognosis compared with the chemotherapy group, with a manageable safety profile. Therefore, this study aims to observe and evaluate the efficacy and safety of vicinecumab in the second-line and subsequent treatment of advanced biliary tract tumors.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 22, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 22, 2026
Actual (reported)October 16, 2026
Actual (reported)October 22, 2026
Actual (reported)September 22, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 22, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Objective Response Rate
ORR assessed by investigator according to RECIST version 1.1 (CR + PR).
From first study drug administration until documented disease progression or death, up to approximately 24 months.
Progression-Free Survival (PFS)
Up to approximately 24 months.
Disease Control Rate (DCR)
From first dose until disease progression, up to approximately 24 months.
Time from first dose to death from any cause.
Up to approximately 30 months.
Safety-Incidence of Adverse Events (AEs) and Serious Adverse Events
From signing informed consent through 30 days after last study drug dose.
Becotatug vedotin 2.3 mg/kg, intravenous infusion over 60 minutes (±15 min), Q3W (every 21 days).
Jiangmen Central Hospital
Jiangmen, Guangdong, 529030, China
First Submitted
October 16, 2026
First Posted
October 22, 2026
Study Start
September 22, 2026
Actual (reported)Primary Completion
September 22, 2027
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 22, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 26, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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