Trials / Recruiting
RecruitingNCT07068542
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 94 (estimated)
- Sponsor
- Zhejiang Provincial People's Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Advanced Thyroid Carcinoma
- Radioiodine-refractory Differentiated Thyroid Cancer
- Poorly Differentiated Thyroid Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sacituzumab Tirumotecan (SKB264) plus Tislelizumab | Sacituzumab tirumotecan: 5mg/kg, IV, Q6W, D1, D15, D29 Tislelizumab: 200mg, IV, Q6W, D1, D15, D29 |
| DRUG | Sacituzumab Tirumotecan (SKB264) | Sacituzumab tirumotecan: 5mg, IV, Q6W, D1, D15, D29 |
Timeline
- Start date
- 2025-07-01
- Primary completion
- 2027-12-31
- Completion
- 2028-12-31
- First posted
- 2025-07-16
- Last updated
- 2026-02-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07068542. Inclusion in this directory is not an endorsement.