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.
Anaplastic thyroid carcinoma (ATC), or
Poorly differentiated thyroid carcinoma (PDTC), or
Radioactive iodine-refractory differentiated thyroid carcinoma (RAIR-DTC), including papillary thyroid carcinoma or follicular thyroid carcinoma and variants.
No BRAF V600E mutation, RET fusion, NTRK fusion, or ALK fusion;
Prior therapy targeting TROP2.
Prior treatment with any topoisomerase I inhibitor antibody-drug conjugate.
Prior immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40) or immune cell therapy.
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).
Parallel
Sacituzumab Tirumotecan (SKB264) plus Tislelizumab
DrugSacituzumab tirumotecan: 5mg/kg, IV, Q6W, D1, D15, D29 Tislelizumab: 200mg, IV, Q6W, D1, D15, D29
Sacituzumab Tirumotecan (SKB264)
DrugSacituzumab tirumotecan: 5mg, IV, Q6W, D1, D15, D29
Overall 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).
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.
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).
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.
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.
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.
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