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.
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.
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.
Clinically significant pericardial effusion, pleural effusion, or ascites requiring treatment.
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.
Single group
Sacituzumab Tirumotecan
DrugSacituzumab Tirumotecan 4 mg/kg is administered on Days 1 and 15 of each 28-day (4 week) cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation. The duration of Sacituzumab Tirumotecan infusions should be 90 minutes (±15 minutes) and infusion-related reactions will be monitored. The infusion duration may be adjusted to be longer than 105 minutes at the discretion of the investigator, but the infusion of Sacituzumab Tirumotecan needs to be completed within the timeframe specified in the Pharmacy Manual. After at least 4 administrations and in the absence of either infusion-related reactions or hypersensitivity reactions, the infusion may be shortened at the discretion of the investigator but cannot be shorter than 60 minutes.
Objective Response Rate (ORR) as assessed by the investigator (site assessment).
The objective response rate is defined as the proportion of patients in the full analysis set whose best overall response is a complete response (CR) or partial response (PR) assessed by the investigator (site assessment).
Progression-free survival.
The duration from the date of enrollment to the date of the judgement of progression or death from any cause, whichever comes first. The analysis will rely exclusively on these site assessments (no central review).
Overall survival.
The duration from the date of enrollment to the date of death from any cause.
Disease control rate.
Among full analysis set, the proportion of subjects with either CR, PR, SD best overall response assessed by the investigator.
Proportion of patients with adverse events.
Among safety analysis set, the proportion of subjects with each adverse event. For each adverse event, determine the frequency of the worst Grade by CTCAE v5.0.
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National Cancer Centre, Singapore
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
National Cancer Center, Japan
Collaborator
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