This is a single-arm, Phase II, multicenter clinical trial evaluating sacituzumab tirumotecan in patients with TROP2-positive advanced biliary tract cancer who have experienced disease progression after, or intolerance to, at least one prior line of systemic therapy.
Eligible participants will receive sacituzumab tirumotecan monotherapy. The primary objective is to evaluate objective response rate as assessed by the investigator according to RECIST version 1.1. Secondary objectives include evaluation of progression-free survival, overall survival, and safety. Exploratory analyses will assess the association between TROP2 protein expression and clinical efficacy, as well as potential mechanisms of resistance.
Age ≥18 years, male or female.
Histologically or cytologically confirmed locally advanced, recurrent, or metastatic biliary tract cancer, with disease progression after, or intolerance to, at least one prior line of systemic therapy.
At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
Prior treatment with any TROP2-directed therapy or any topoisomerase I inhibitor-containing therapy, including antibody-drug conjugate (ADC) therapy, whether administered in the adjuvant, neoadjuvant, or advanced disease setting.
Ongoing or active infection.
Participation in another clinical trial of an antitumor drug within 4 weeks before screening.
History of another uncured malignancy within 5 years, except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix.
Single group
Sacituzumab Tirumotecan (SKB264)
DrugSacituzumab tirumotecan is a TROP2-directed antibody-drug conjugate. It will be administered as monotherapy at 5 mg/kg by intravenous infusion on Day 1 of each 14-day treatment cycle until disease progression, unacceptable toxicity, or other protocol-defined discontinuation criteria.
Objective Response Rate (ORR)
Objective response rate is defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR), as assessed by the investigator according to RECIST version 1.1. Responses of CR or PR will be confirmed by repeat tumor assessment at least 4 weeks after the first documentation of response.
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from the first dose of study treatment to the first documented radiographic disease progression or death from any cause, whichever occurs first.
Overall Survival (OS)
Overall survival is defined as the time from the first dose of study treatment to death from any cause.
Incidence and Severity of Adverse Events
Safety will be assessed by the incidence, severity, and relationship to study treatment of adverse events (AEs), treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs). Safety assessments will also include adverse events leading to dose reduction, treatment interruption, treatment discontinuation, study withdrawal, or death. Adverse event severity will be graded according to NCI CTCAE version 5.0.
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Collaborator
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