A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors (NCT06248515) | Clinical Trial Compass
RecruitingPhase 2
A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors
United States18 participantsStarted 2024-04-25
Plain-language summary
The goal of this clinical trial is to study the effect of sacituzumab govitecan-hziy in adult patients with advanced thymoma and thymic carcinoma after progressing on at least one prior line of therapy.
The main question it aims to answer is:
• What is the overall response rate (ORR) in patients with advanced thymoma and thymic carcinoma?
Participants will:
* receive a fixed dose of 10 mg/kg given intravenously, once weekly on Days 1 and 8 of continuous 21-day treatment cycles until disease progression or unacceptable toxicity
* have regular blood tests, scans, and examinations to monitor their health.
* have blood and a biopsy of their tumor for research purposes.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \>/= 18 years at time of signing informed consent form (ICF)
* Ability to understand and the willingness to sign a written informed consent document
* Patients with histologically confirmed advanced thymoma or thymic carcinoma
* Patients who have experienced disease progression after treatment with at least one prior systemic therapy
* Measurable disease per RECIST v1.1
* Availability of pre-treatment tumor tissue (archival or fresh); If archival tissue is not available and a fresh biopsy is not considered safe and medically feasible by the Investigator, the patient may be approved for enrollment after consultation with the Principal Investigator
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
* Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
* Absolute neutrophil count (ANC) \>/= 1.5 x 10\^9/L (1500/uL) without filgrastim support
* Platelet count \>/= 100 x 10\^9/L (100,000/uL) without transfusion
* Hemoglobin (Hgb) \>/= 80 g/L (8 g/dL). Patients may be transfused to meet this criterion.
* Aspartate aminotransferase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP) \</= 2.5 x upper limit of normal (ULN), with the following exceptions:
* Patients with documented liver metastases: AST and ALT \</= 5 x ULN
* Patients with documented liver or bone metastases: ALP \</= 5 x ULN Serum bilirubin \</= 1.5 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.