Actively Recruiting
A Multicenter, Multi-Cohort, Phase II Study of Sacituzumab Tirumotecan With or Without Tislelizumab in Patients With Advanced Thyroid Cancer
Led by Zhejiang Provincial People's Hospital · Updated on 2026-06-01
94
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating sacituzumab tirumotecan with or without tislelizumab in patients with advanced forms of thyroid cancer, including unresectable, locally advanced, or metastatic anaplastic thyroid carcinoma (ATC), poorly differentiated thyroid carcinoma (PDTC), and radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC). This exploratory Phase II study aims to assess the safety and effectiveness of these treatments, with a focus on overall survival in the ATC group and progression-free survival in the PDTC and RAIR-DTC groups. Patients with ATC will receive a combination of sacituzumab tirumotecan and tislelizumab administered intravenously every six weeks on specific days. Those with PDTC or RAIR-DTC will receive sacituzumab tirumotecan alone on the same schedule. The study is open-label and includes multiple cohorts based on cancer type, with treatment continuing up to approximately 24 months. Participants will be closely monitored through regular assessments including imaging to measure tumor response, survival status, and side effects. Researchers will track overall survival and progression-free survival as primary outcomes, along with response rates and safety events, up to two years following treatment initiation. The study involves ongoing safety follow-up and comprehensive data collection to understand the effects of these therapies in advanced thyroid cancer.
CONDITIONS
Brief 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)
- For ATC or PDTC: no BRAF V600E mutation, RET fusion, NTRK fusion, or ALK fusion; or have failed prior standard first-line targeted therapy if these alterations are present
- For RAIR-DTC: disease refractory to radioactive iodine defined by specific criteria including no uptake in lesions or progression after therapy
- At least one measurable lesion according to RECIST version 1.1
- ECOG performance status 0-2
- Life expectancy of 12 weeks or more
- Adequate blood, liver, and kidney function as defined by lab values
- 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 prior to first dose except certain localized cancers
- Uncontrolled or symptomatic central nervous system metastases (unless stable and off corticosteroids for set periods)
- Significant uncontrolled comorbidities such as uncontrolled hypertension, severe diabetes, or active infection
- History or suspicion of interstitial lung disease or non-infectious pneumonitis requiring steroids
- Unresolved toxicities from prior anti-cancer therapy greater than Grade 1 (except alopecia or minor toxicities)
- Active autoimmune disease requiring systemic treatment within past 2 years (excluding hormone replacement or physiologic corticosteroids)
- Systemic corticosteroid use over 10 mg/day prednisone equivalent within 10 days prior to first dose (except certain exceptions)
- Known HIV infection, AIDS, or active syphilis
- History of allogeneic organ or stem cell transplantation
- Known severe hypersensitivity to study drugs or components
- Recent chemotherapy, radiotherapy, immunotherapy, biologic therapy, TKI, or systemic immune stimulation within washout period
- Pregnant or breastfeeding women
- Severe ocular disorders interfering with corneal healing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 24 months or until disease progression or discontinuation
Participants receive Sacituzumab Tirumotecan with or without Tislelizumab through intravenous infusions every 6 weeks on specified days to treat advanced thyroid cancer.
Infusions every 6 weeks on Days 1, 15, and 29 in the initial cycle with subsequent dosing every 6 weeks
Duration - Up to 90 days after last dose
Participants are monitored for safety and adverse events for up to 90 days after the last treatment dose.
Approximately 1 to 2 visits for safety monitoring
Trial Site Locations
Total: 1 location
1
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310014
Actively Recruiting
Research Team
K
Kexin Meng
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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