Sacituzumab Tirumotecan in Previously Treated TROP2-Positive Advanced Biliary Tract Cancer

NCT07701122 | Not Yet Recruiting Phase 2

• 1 other identifier: SKB264-SSIP-023
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Advanced Biliary Tract Cancer(BTC)

Keywords

Biliary Tract Cancer; TROP2; Sacituzumab Tirumotecan; Antibody-Drug Conjugate

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Secondary Outcomes (3)

• Progression-Free Survival (PFS)

  From the first dose of study treatment until radiographic disease progression, death, withdrawal, loss to follow-up, or study completion, assessed up to approximately 24 months.

• Overall Survival (OS)

  From the first dose of study treatment until death from any cause, withdrawal, loss to follow-up, or study completion, assessed up to approximately 24 months.

• Incidence and Severity of Adverse Events

  From informed consent through 30 days after the last dose of study treatment, or until the start of new anticancer therapy, whichever occurs first.

Study Arms (1)

Treatment group

EXPERIMENTAL

Participants in this arm will receive sacituzumab tirumotecan monotherapy at 5 mg/kg by intravenous infusion on Day 1 of each 14-day treatment cycle. Treatment will continue until radiographic disease progression, unacceptable toxicity, withdrawal of consent, investigator decision, or other protocol-defined treatment discontinuation criteria. Tumor assessments will be performed according to RECIST version 1.1, with the first post-treatment assessment planned after 4 doses of study treatment.

Drug: Sacituzumab Tirumotecan (SKB264)

Interventions

Sacituzumab Tirumotecan (SKB264) DRUG

Sacituzumab 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.

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following criteria to be eligible for enrollment:
• 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:
• Hematology: absolute neutrophil count ≥1.5 × 10\^9/L; platelet count ≥80 × 10\^9/L; hemoglobin ≥90 g/L.
• Liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤2.5 × upper limit of normal (ULN); total bilirubin ≤1.5 × ULN; albumin ≥30 g/L. For participants with liver metastases at baseline, ALT and AST must be ≤5 × ULN and total bilirubin must be ≤3 × ULN.
• Renal function: serum creatinine ≤1.5 × ULN, or creatinine clearance ≥50 mL/min as calculated using the standard Cockcroft-Gault formula.
• Coagulation function: international normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) ≤1.5 × ULN.
• Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective medically accepted contraception from the time of signing the informed consent form until 6 months after the last dose of study treatment.
• Voluntarily agrees to participate in the study, provides written informed consent, has good compliance, and is willing to cooperate with study follow-up.

You may not qualify if:

• Participants who meet any of the following criteria will be excluded:
• 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.
• Deep vein thrombosis within 3 months before the first dose of study treatment, unless stable for ≥2 weeks after treatment with low-molecular-weight heparin or a drug with similar efficacy; peripheral arterial thromboembolic event, pulmonary embolism, or other severe thromboembolic event within 3 months before the first dose of study treatment.
• Life-threatening major vascular disease, such as aortic aneurysm or aortic dissecting aneurysm, or major vascular disease requiring surgery within 6 months before the first dose of study treatment.
• Uncontrolled systemic disease as judged by the investigator, including:
• Poorly controlled diabetes mellitus, defined as fasting blood glucose ≥10 mmol/L on two consecutive tests.
• Poorly controlled hypertension, defined as systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg.
• Symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once per week.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: collaborator

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Central Study Contacts

Jun Xue, Doctor

CONTACT

027-83262682; junxue_xh@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 14, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 14, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share