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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
94
Sacituzumab tirumotecan: 5mg/kg, IV, Q6W, D1, D15, D29 Tislelizumab: 200mg, IV, Q6W, D1, D15, D29
Sacituzumab tirumotecan: 5mg, IV, Q6W, D1, D15, D29
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
RECRUITINGOverall Survival (OS) - ATC Cohort
Overall survival is defined as the time from the first dose of study treatment to death from any cause in patients with unresectable or metastatic anaplastic thyroid carcinoma (ATC).
Time frame: From first dose until death from any cause (up to approximately 24 months after enrollment)
Progression-Free Survival (PFS) - PDTC and RAIR-DTC Cohorts
Progression-free survival is defined as the time from the first dose of study treatment to the first documented radiographic disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first, in patients with PDTC and RAIR-DTC.
Time frame: From first dose until documented disease progression or death (up to approximately 24 months)
Progression-Free Survival (PFS) - ATC Cohort
Progression-free survival is defined as the time from the first dose of study treatment to the first documented radiographic disease progression per RECIST version 1.1 or death from any cause, whichever occurs first, in patients with anaplastic thyroid carcinoma (ATC).
Time frame: From first dose until documented disease progression or death (up to approximately 24 months)
Overall Survival (OS) - PDTC and RAIR-DTC Cohorts
Overall survival is defined as the time from the first dose of study treatment to death from any cause in patients with PDTC and RAIR-DTC.
Time frame: From first dose until death from any cause (up to approximately 24 months)
Objective Response Rate (ORR)
Objective response rate is defined as the proportion of patients achieving complete response (CR) or partial response (PR) as their best overall response according to RECIST version 1.1.
Time frame: Up to approximately 24 months
Disease Control Rate (DCR)
Disease control rate is defined as the proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST version 1.1.
Time frame: Up to approximately 24 months
Duration of Response (DoR)
Duration of response is defined as the time from first documented objective response (CR or PR) until radiographic disease progression or death from any cause, whichever occurs first.
Time frame: Up to approximately 24 months
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Incidence, severity, and relationship of treatment-emergent adverse events graded according to NCI CTCAE version 5.0.
Time frame: From first dose until 30 days after last dose (SAEs up to 90 days)
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