Thymic Carcinoma
Conditions
Brief summary
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.
Interventions
DRUGSacituzumab tirumotecan
Sacituzumab tirumotecan (Sac-TMT; also known as SKB264) for injection.
Sponsors
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | From enrollment to the end of treatment at 24 months | To evaluate the objective response rate (ORR) of sac-TMT as assessed by the investigator based on RECIST v1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | From enrollment to the end of treatment at 24 months | To evaluate the progression-free survival (PFS) as assessed by the investigator based on RECIST v1.1. |
| OS | From enrollment to the end of treatment at 24 months | To evaluate the overall survival (OS) of sac-TMT in participants with locally advanced or metastatic thymic carcinoma with treatment failure after platinum-based therapy. |
| Incidence and severity of AEs and SAEs, and abnormal laboratory values. | From enrollment to the end of treatment at 24 months | To evaluate the safety of sac-TMT in participants with locally advanced or metastatic thymic carcinoma. |
| DCR | From enrollment to the end of treatment at 24months | Duration of response (DOR) as assessed by the investigator based on RECIST v1.1. |
Countries
China
Contacts
CONTACTYan Qing
Outcome results
None listed