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NOT YET RECRUITING
NCT07343453
PHASE2

A Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan in Second-Line and Subsequent Treatments for Advanced Thymic Epithelial Tumors

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This is a single-arm, phase II study to evaluate the efficacy and safety of Sacituzumab Tirumotecan, a TROP2-directed antibody-drug conjugate, in patients with advanced thymic epithelial tumors who have received second-line or later therapy.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2025-12-22

Completion Date

2029-12-22

Last Updated

2026-01-15

Healthy Volunteers

No

Interventions

DRUG

Sacituzumab tirumotecan

Sacituzumab Tirumotecan is an antibody-drug conjugate (ADC) composed of a humanized anti-TROP2 monoclonal antibody of the IgG1 class covalently linked to the cytotoxic payload KL610023, a topoisomerase I inhibitor. Its mechanism of action involves: (1) specific binding of the antibody to Trop-2 on the tumor cell membrane, followed by internalization; (2) lysosomal degradation leading to the release of SN-38, which induces DNA double-strand breaks; and (3) a bystander effect that kills adjacent Trop-2-negative cells.