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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
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.
Objective response rate(ORR)
ORR, per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR).
Time frame: Within one year after starting treatment.
Progression free survival (PFS)
The time interval from the first dose of study medication to the first record of disease progression or death from any cause, whichever occurred first.
Time frame: Within two year after the first treatment
Disease control rate (DCR)
The proportion of subjects who achieved the best total efficacy was to confirm CR or PR or SD (according to iRECIST).
Time frame: Within one year after starting treatment.
Duration of remission (DOR)
The time from the first record of confirmed remission (CR or PR) to the first record of disease progression (according to irecist) or death due to any cause, whichever occurs first.
Time frame: Within one year after starting treatment.
Overall survival (OS)
OS is defined as the time from the first administration of the study drug until the date of death from any cause. For subjects who are alive at the data cutoff, censoring will occur at the last known date of survival. Subjects with no follow-up information provided will be censored on the date of enrollment.
Time frame: Assessed from enrollment to death or last known survival, up to 4 years post-enrollment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.