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.
Advanced (unresectable or metastatic) thymic epithelial tumor confirmed by histology or cytology.
Progress after receiving at least first-line systemic therapy (chemotherapy or immune checkpoint inhibitor).
According to RECISTv1.1 standard, there is at least one measurable lesion.
No central nervous system metastasis or stable brain metastasis after treatment (asymptomatic and hormone withdrawal for ≥4 weeks).
Previously received targeted drug therapy with Lucasatuzumab.
Have received any drug therapy targeting topoisomerase I in the past, including antibody-coupled drug (ADC) therapy.
Patients with grade 3-4 interstitial lung disease.
Subjects known to have meningeal metastasis, brain stem metastasis, spinal cord metastasis and/or compression, active or brain metastasis without local treatment. 5.Subjects with brain metastases who have previously received local treatment can participate in the study if they are clinically stable for at least 4 weeks before the first administration of the study treatment and do not need to use corticosteroids or anticonvulsants for at least 14 days before the first administration; For the subjects with brain metastases first discovered during screening, if they receive local treatment (such as radiotherapy), they must have imaging evidence to show that the brain metastases have not progressed for at least 4 weeks from the first imaging diagnosis of brain metastases, and they can only enter the group after confirming that the brain metastases are stable.
Single group
Sacituzumab tirumotecan
DrugSacituzumab 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).
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.
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).
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.
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.
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