Overview
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.
Eligibility
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.
