A Phase II, Investigator-Initiated Exploratory Study of Sacituzumab Tirumotecan for Previously Tr… (NCT07750353) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase II, Investigator-Initiated Exploratory Study of Sacituzumab Tirumotecan for Previously Treated Unresectable Thymic Carcinomas
Japan35 participantsStarted 2027-02-01
Plain-language summary
This is a non-randomized, open-label, investigator-initiated phase II clinical trial designed to evaluate the efficacy and safety of sacituzumab tirumotecan (hereafter referred to as sac-TMT) in patients with unresectable thymic carcinoma who have a history of platinum-based combination chemotherapy.
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
. Pathologically diagnosed (histological or cytological examination) as thymic carcinoma originating in the thymus or from a metastatic site Immunohistochemical staining including diagnostic marker testing is recommended. If performed prior to registration, the timing is not restricted. However, if histological examination was conducted at another institution, the pathological diagnosis must generally be obtained by a pathologist at the study site, e.g., by requesting the pathological specimen.)
. Meets any of the following criteria:
. Thymic carcinoma was classified as Stage IV by the Masaoka-Koga staging at initial diagnosis
. Thymic carcinoma was classified as Stage III by the Masaoka-Koga staging at initial diagnosis and was judged to be unresectable with curative resection
. The disease is a postoperative recurrence of thymic carcinoma
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.
What they're measuring
1
Objective response rate based on central image review
Timeframe: Baseline up to 3 years. Overall Response is assessed every 8 weeks until 24 weeks after initiation of protocol treatment, and every 12 weeks after 25 weeks and after termination. It continues until PD confirmation or post-study treatment initiation.
. The patients do not have symptomatic brain metastases, carcinomatous meningitis, or spinal metastases requiring radiation therapy or surgical intervention
. The patients do not have pericardial effusion, pleural effusion, or ascites requiring treatment
. Age ≥ 18 years at registration
Exclusion criteria
. Patients with thymoma and immune complications associated with thymoma (such as myasthenia gravis, aplastic anemia, hypogammaglobulinemia (Good syndrome), etc.)
. Patients with intestinal paralysis or intestinal obstruction
. Patients with a history of severe dry eye syndrome, severe meibomian gland disease, or severe corneal disease (impeding or delaying corneal healing)
. Uncontrolled major cardiovascular or cerebrovascular disease (NYHA Class III or IV heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, QTcF interval \>480 ms, or other major cardiovascular or cerebrovascular disease within 6 months prior to enrollment
. Patients with unresolved stomatitis greater than Grade 1 at the time of registration are excluded. Prophylactic supportive care measures for stomatitis are permitted, provided there are no active stomatitis-related symptoms.
. Previous treatment history with a TROP2-targeted ADC (such as sacituzumab govitecan)
. Previous treatment history with topoisomerase I inhibitors (irinotecan, topotecan) or ADCs containing topoisomerase I inhibitors (e.g., trastuzumab deruxtecan)
. Received a live or live-attenuated vaccine within 30 days prior to the registration date. Inactivated vaccines may be administered.