Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thymic Carcinoma | Thymus Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sacituzumab tirumotecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sac-TMT 5mg/kg Q2W
- interventionNames
- Drug: Sacituzumab tirumotecan
Primary outcomes (1)
- measure
- ORR
- timeFrame
- From enrollment to the end of treatment at 24 months
- description
- To evaluate the objective response rate (ORR) of sac-TMT as assessed by the investigator based on RECIST v1.1.
Secondary outcomes (4)
- measure
- PFS
- timeFrame
- From enrollment to the end of treatment at 24 months
- description
- To evaluate the progression-free survival (PFS) as assessed by the investigator based on RECIST v1.1.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available