Sacituzumab Tirumotecan Combined With Immunotherapy in Advanced Thyroid Cancer (NCT07068542) | Clinical Trial Compass
RecruitingNot Applicable
Sacituzumab Tirumotecan Combined With Immunotherapy in Advanced Thyroid Cancer
China94 participantsStarted 2025-07-01
Plain-language summary
This is a multicenter, open-label, multi-cohort Phase II exploratory study designed to evaluate the efficacy and safety of sacituzumab tirumotecan with or without tislelizumab in patients with unresectable, locally advanced, or metastatic anaplastic thyroid carcinoma (ATC), poorly differentiated thyroid carcinoma (PDTC), or radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC).
Patients with ATC will receive sacituzumab tirumotecan in combination with tislelizumab. Patients with PDTC and RAIR-DTC will receive sacituzumab tirumotecan monotherapy.
The primary objective in the ATC cohort is overall survival (OS). In the PDTC and RAIR-DTC cohorts, the primary objective is progression-free survival (PFS) assessed by investigators per RECIST v1.1.
Who can participate
Age range18 Years
SexALL
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
✓. No active autoimmune disease requiring systemic therapy.
✓. No concurrent active malignancy requiring treatment.
✓. Willing and able to provide written informed consent.
Exclusion criteria
✕. Prior therapy targeting TROP2.
✕. Prior treatment with any topoisomerase I inhibitor antibody-drug conjugate.
✕. Another malignancy within 3 years prior to first dose, except adequately treated localized cancers (e.g., basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ of the cervix).
✕. Uncontrolled or symptomatic central nervous system metastases.
✕. Significant uncontrolled comorbidities including, but not limited to:
✕
What they're measuring
1
Overall Survival (OS) - ATC Cohort
Timeframe: From first dose until death from any cause (up to approximately 24 months after enrollment)
2
Progression-Free Survival (PFS) - PDTC and RAIR-DTC Cohorts
Timeframe: From first dose until documented disease progression or death (up to approximately 24 months)
. History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroids, or current suspected ILD.
✕. Unresolved toxicities from prior anti-cancer therapy greater than Grade 1 (CTCAE v5.0), except alopecia or other clinically insignificant toxicities.