Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma
NCT ID: NCT07324629
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2026-01-31
2028-10-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sac-TMT 5mg/kg Q2W
Sacituzumab tirumotecan
Sacituzumab tirumotecan (Sac-TMT; also known as SKB264) for injection.
Interventions
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Sacituzumab tirumotecan
Sacituzumab tirumotecan (Sac-TMT; also known as SKB264) for injection.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Shanghai Chest Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SKB264-II-17
Identifier Type: -
Identifier Source: org_study_id
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