RecruitingNot ApplicableNCT07068542

Sacituzumab Tirumotecan Combined With Immunotherapy in Advanced Thyroid Cancer

A Multicenter, Multi-Cohort, Phase II Study of Sacituzumab Tirumotecan With or Without Tislelizumab in Patients With Advanced Thyroid Cancer


Sponsor

Zhejiang Provincial People's Hospital

Enrollment

94 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of a targeted antibody-drug conjugate (sacituzumab tirumotecan, which delivers chemotherapy directly to cancer cells) and immunotherapy in people with advanced or metastatic thyroid cancer that has not responded to standard treatments. **You may be eligible if...** - You are 18 or older with confirmed advanced anaplastic, poorly differentiated, or radioactive iodine-resistant differentiated thyroid cancer - Your cancer has progressed on or after standard targeted therapy (if a relevant mutation is present) - You have measurable disease and are in reasonably good physical condition - Your blood counts and organ function meet acceptable thresholds **You may NOT be eligible if...** - You have previously received a drug targeting TROP2 or a topoisomerase I inhibitor antibody-drug conjugate - You have active brain metastases causing symptoms - You have an active autoimmune disease requiring systemic treatment - You have interstitial lung disease - You are pregnant or breastfeeding - You have HIV or active syphilis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab Tirumotecan (SKB264) plus Tislelizumab

Sacituzumab tirumotecan: 5mg/kg, IV, Q6W, D1, D15, D29 Tislelizumab: 200mg, IV, Q6W, D1, D15, D29

DRUGSacituzumab Tirumotecan (SKB264)

Sacituzumab tirumotecan: 5mg, IV, Q6W, D1, D15, D29


Locations(1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

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NCT07068542


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