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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Sacituzumab tirumotecan

Treatment groups

38 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators