Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma

A Phase II Clinical Study of Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma With Treatment Failure After Platinum-Based Therapy

The goal of this clinical trial is to learn if drug Sac-TMT works to treat Thymic Carcinoma. It will also learn about the safety of Sac-TMT. The main questions it aims to answer are:

• How effective is drug Sac-TMT in treating Thymic Carcinoma?
• What adverse events (AEs) do participants have when taking drug Sac-TMT?

Participants will:

• Progress after at least one platinum-based chemotherapy treatment.
• Take drug Sac-TMT every 2 weeks.
• Take tumor response assessments every 6 weeks.

Inclusion Criteria:

• Males or females aged ≥ 18 to ≤ 75 years at the time of signing the Informed Consent Form;
• Participants with histologically or cytologically confirmed thymic carcinoma, and locally advanced or metastatic thymic carcinoma who are not suitable for curative intent therapy;
• Participants with advanced thymic carcinoma who have progressed after at least one prior platinum-based chemotherapy;
• Able to provide a tumor tissue sample at the time of or after the diagnosis of locally advanced or metastatic tumor;
• At least one measurable target lesion that has not received radiotherapy according to RECIST v1.1;
• ECOG performance status score of 0 or 1;
• Expected survival ≥ 12 weeks;
• Adequate organ and bone marrow function.

Exclusion Criteria:

• Participants with histologically or cytologically confirmed thymoma or thymic neuroendocrine tumor;
• Participants with known metastases to meninges, brainstem metastases, spinal cord metastases and/or compression, active or untreated brain metastases;
• Participants with other malignant tumors within 3 years prior to the first dose;
• Presence of any of conditions or risk factors related to cardiovascular and cerebrovascular diseases;
• Uncontrolled systemic disease as judged by the investigator;
• History of interstitial lung disease/noninfectious pneumonitis requiring steroid therapy;
• Clinically severe pulmonary impairment due to lung disorder;
• Presence of active hepatitis B or hepatitis C;
• Known active tuberculosis;
• Known hypersensitivity to the study drug or any of its components.