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

NCT07701122 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-07-14

No results posted yet for this study

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)

Interventions

DRUG

Sacituzumab Tirumotecan (SKB264)

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.

Sponsors & Collaborators

  • Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-07-01
Completion
2028-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07701122 on ClinicalTrials.gov