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
Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
ORR
Time frame: From enrollment to the end of treatment at 24 months
Secondary Endpoints
PFS
OS
Incidence and severity of AEs and SAEs, and abnormal laboratory values.
Eligibility Criteria
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 …
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