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 range18 Years – 99 Years
SexALL
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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).
✓. 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.
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 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.