Sacituzumab Tirumotecan in Recurrent/Metastatic Adenoid Cystic Carcinoma and Papillary Thyroid Carcinoma (STRAP)
A Phase II Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan in Patients With Recurrent/Metastatic Adenoid Cystic Carcinoma and Papillary Thyroid Carcinoma (STRAP, ATLAS2501 NCCH2413/MK016)
Sponsor: National Cancer Centre, Singapore + Merck Sharp & Dohme LLC, National Cancer Center, Japan
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
Objective Response Rate (ORR) as assessed by the investigator (site assessment).
Time frame: 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.
Secondary Endpoints
Progression-free survival.
Overall survival.
Disease control rate.
Eligibility Criteria
Inclusion Criteria: Common Eligibility Criteria for Cohorts A and B 1. Unresectable locally advanced or recurrent/metastatic adenoid cystic carcinoma or papillary thyroid carcinoma. 2. 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. 3. Age ≥18 years at the time of enrollment (≥21 years in Singapore) 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. 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…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
Request coverage →