Sacituzumab Tirumotecan in Recurrent/Metastatic Adenoid Cystic Carcinoma and Papillary Thyroid Ca… (NCT07521670) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Sacituzumab Tirumotecan in Recurrent/Metastatic Adenoid Cystic Carcinoma and Papillary Thyroid Carcinoma (STRAP)
Japan, Malaysia, Singapore68 participantsStarted 2026-05
Plain-language summary
This is an open-label, investigator-initiated phase II clinical trial designed to evaluate the efficacy and safety of Sacituzumab Tirumotecan (sac-TMT) monotherapy in patients with recurrent or metastatic adenoid cystic carcinoma (ACC) of salivary gland origin and papillary thyroid carcinoma (PTC). A total of 68 patients will be enrolled over in 18-month period, with 34 patients in Cohort A (ACC) and 34 in Cohort B (PTC). All participants will receive sac-TMT at a dose of 4 mg/kg administered intravenously on Days 1 and 15 of each 28-day cycle.
The primary endpoint is the objective response rate (ORR), defined as the proportion of patients achieving a complete or partial response as assessed by the site investigators. Secondary endpoints include progression-free survival, overall survival, disease control rate, safety and tolerability, dose intensity, and relative dose intensity.
Who can participate
Age range
18 Years – 99 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
. Unresectable locally advanced or recurrent/metastatic adenoid cystic carcinoma or papillary thyroid carcinoma.
. Trophoblast cell-surface antigen 2 (TROP2) expression testing by immunohistochemistry or other methods is not required for enrollment. Provision of archival tumour tissue (where available) will be requested to support retrospective analysis. Waiver for tissue submission may be granted by the Steering Committee on a case-by-case basis if archival tissue is unavailable or insufficient for analysis.
. Age ≥18 years at the time of enrollment (≥21 years in Singapore)
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
. At least one target lesion \*identified on contrast-enhanced CT (head, neck, chest, abdomen, pelvis with ≤5 mm slice thickness) performed within 14 days prior to enrollment (same day of the week within 14 days is acceptable; this applies similarly to other time-based criteria below).
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 (ORR) as assessed by the investigator (site assessment).
Timeframe: Every 8 weeks until 48 weeks, then every 12 weeks after 49 weeks after the initiation of protocol treatments, until disease progression, initiation of post-study treatment, or study completion, approximately 2.5 years.
Trial details
NCT IDNCT07521670
SponsorNational Cancer Centre, Singapore
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2028-10-31
Contact for this trial
Darren Wan-Teck Lim, MBBS (S'pore), MRCP (UK), FAMS
. No prior treatment with Trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugates or antibody-drug conjugates containing anti-topoisomerase I agents.
. Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or pre-treatment baseline level (except for alopecia and vitiligo). Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible.
. No administration of anticancer therapies (e.g., chemotherapy, targeted therapy, immunotherapy) within 13 days prior to enrollment.
Exclusion criteria
. Active central nervous system (CNS) metastases - including brain metastases, carcinomatous (leptomeningeal) meningitis, or symptomatic spinal metastases that require radiotherapy or surgical intervention. However, patients with previously treated brain metastases may be enrolled if imaging performed at screening shows radiographic stability for at least 28 days with no evidence of progression, they are clinically stable, and they have not required steroid therapy for at least 14 days before enrollment.
. Has a current and past history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \>480 ms, prior treatment history with cardiotoxic agents and/or other serious cardiovascular and cerebrovascular diseases within 6 months before enrollment.
. Received a live or live-attenuated vaccine within 30 days before enrollment. Administration of inactivated vaccines are allowed.
. Is currently receiving a strong inducer/inhibitor of CYP3A4 that cannot be discontinued for the duration of treatment with study intervention. The required washout period before starting study intervention is 2 weeks.
. Is currently participating in another therapeutic clinical trial. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anti-cancer therapy is prohibited.
. Has received an investigational agent or has used an investigational device within 28 days before enrollment.