Actively Recruiting
Sacituzumab Tirumotecan Combined With Immunotherapy in Advanced Thyroid Cancer
Led by Zhejiang Provincial People's Hospital · Updated on 2026-02-24
94
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Sacituzumab Tirumotecan Combined With Immunotherapy in Advanced Thyroid Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of informed consent
- Histologically confirmed unresectable, locally advanced, or metastatic anaplastic thyroid carcinoma (ATC), poorly differentiated thyroid carcinoma (PDTC), or radioactive iodine-refractory differentiated thyroid carcinoma (RAIR-DTC), including papillary or follicular types
- For ATC or PDTC: no BRAF V600E mutation, RET fusion, NTRK fusion, or ALK fusion; or have these alterations but failed prior standard first-line targeted therapy
- For RAIR-DTC: disease refractory to radioactive iodine, shown by no RAI uptake, progression within 12 months after RAI therapy, high cumulative RAI dose, FDG-avid measurable disease, or failure of prior multi-target tyrosine kinase inhibitor therapy
- At least one measurable lesion per RECIST version 1.1
- ECOG performance status of 0 to 2
- Life expectancy of at least 12 weeks
- Adequate blood cell counts: neutrophils ≥ 1.2 x 10⁹/L, platelets ≥ 100 x 10⁹/L, hemoglobin ≥ 90 g/L
- Adequate liver function: AST and ALT ≤ 2.5 times the upper normal limit, or ≤ 5 times if liver metastases present; total bilirubin ≤ 1.5 times upper normal limit
- Adequate kidney function: creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula)
- No active autoimmune disease requiring systemic therapy
- No concurrent active malignancy needing treatment
- Willing and able to provide written informed consent
You will not qualify if you...
- Prior therapy targeting TROP2
- Prior treatment with any topoisomerase I inhibitor antibody-drug conjugate
- Prior immune checkpoint agonists or immune cell therapy
- Another malignancy within 3 years except certain localized cancers
- Uncontrolled or symptomatic central nervous system metastases (stable CNS disease treated and corticosteroid-free for at least 4 and 2 weeks respectively may be eligible)
- Significant uncontrolled comorbidities such as uncontrolled hypertension, severe diabetes, or active infection
- History or current suspected interstitial lung disease or non-infectious pneumonitis requiring steroids
- Unresolved toxicities from prior cancer therapy greater than Grade 1 except alopecia or minor toxicities
- Active autoimmune disease requiring systemic treatment within past 2 years (except hormone replacement or physiologic corticosteroids)
- Systemic corticosteroid use over 10 mg/day prednisone equivalent within 10 days prior to first dose (except inhaled, topical, or physiological doses)
- Known HIV infection, AIDS, or active syphilis infection
- History of allogeneic organ or hematopoietic stem cell transplantation
- Known severe hypersensitivity to study drugs or components
- Recent chemotherapy, radiotherapy, immunotherapy, biologic therapy, tyrosine kinase inhibitors, or systemic immune stimulation within protocol-specified washout periods
- Pregnant or breastfeeding women
- Severe eye disorders interfering with corneal healing such as severe dry eye or meibomian gland disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310014
Actively Recruiting
Research Team
K
Kexin Meng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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