NCT07343453

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study aims 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. The study is designed as a prospective, single-arm, phase II clinical trial. Eligible patients must meet the inclusion/exclusion criteria, have received prior systemic therapy, and have a pathological diagnosis of advanced thymic epithelial tumor. Enrolled patients will receive Sacituzumab Tirumotecan at a dose of 5 mg/kg via intravenous infusion. Treatment cycles repeat every 4 weeks, with administration on Day 1 and Day 15 of each cycle. Treatment will continue until disease progression (as defined by loss of clinical benefit), intolerable toxicity, patient withdrawal, or meeting other protocol-specified discontinuation criteria. The primary endpoint of this study is the Objective Response Rate (ORR), defined as the proportion of patients achieving a confirmed Complete Response (CR) or Partial Response (PR) as their best overall response, assessed according to RECIST version 1.1. Secondary endpoints include Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DOR), Overall Survival (OS), incidence of Adverse Events (AEs), and Quality of Life (QoL) assessments. Following treatment discontinuation, subjects will enter a follow-up phase consisting of safety follow-up and survival follow-up, with survival status assessed every 90 days.

Conditions

• Thymic Epithelial Tumors
• Advanced Stage
• Second-line Therapy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-22
• Primary completion: 2027-12-22
• Completion: 2029-12-22
• First posted: 2026-01-15
• Last updated: 2026-01-15