Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sacituzumab tirumotecan.
- Who it may be relevant to
- Registry conditions: Thymic Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase II Clinical Study of Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma With Treatment Failure After Platinum-Based Therapy
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.
Interventions
- Drug Sacituzumab tirumotecan
Sacituzumab tirumotecan (Sac-TMT; also known as SKB264) for injection.
Primary outcome measures
- ORR [Time frame: From enrollment to the end of treatment at 24 months]
Secondary outcome measures (4)
- PFS [Time frame: From enrollment to the end of treatment at 24 months]
- OS [Time frame: From enrollment to the end of treatment at 24 months]
- Incidence and severity of AEs and SAEs, and abnormal laboratory values. [Time frame: From enrollment to the end of treatment at 24 months]
- DCR [Time frame: From enrollment to the end of treatment at 24months]
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Chest Hospital — Shanghai
Identifiers
NCT: NCT07324629 · SKB264-II-17