Sacituzumab Tirumotecan in Previously Treated TROP2-Positive Advanced Biliary Tract Cancer (NCT07701122) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Sacituzumab Tirumotecan in Previously Treated TROP2-Positive Advanced Biliary Tract Cancer
33 participantsStarted 2026-07-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. TROP2 expression by immunohistochemistry (IHC) ≥1+.
. Life expectancy of at least 3 months.
. Adequate organ and bone marrow function, without transfusion, recombinant human thrombopoietin, or colony-stimulating factor treatment within 2 weeks before the first dose of study treatment, defined as follows:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: From first dose until disease progression, new anticancer therapy, withdrawal, loss to follow-up, death or study end, whichever occurs first, assessed up to 24 months. First tumor assessment: Week 8 from first dose, after 4 cycles; each cycle is 14 days.
Trial details
NCT IDNCT07701122
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
. 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.
. Known hypersensitivity to the study drug or any of its components.
. Any of the following cardiovascular or cerebrovascular diseases or risk factors:
. Myocardial infarction, unstable angina, acute or persistent myocardial ischemia, New York Heart Association (NYHA) class III or IV heart failure, symptomatic or poorly controlled severe arrhythmia, cerebrovascular accident, transient ischemic attack, or other severe cardiovascular or cerebrovascular disease within 6 months before the first dose of study treatment.
. History of myocarditis, primary cardiomyopathy, specific cardiomyopathy, or other myocardial disease.