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Advanced Thyroid CarcinomaNCT07068542

Sacituzumab Tirumotecan Combined With Immunotherapy in Advanced Thyroid Cancer

A study testing Sacituzumab Tirumotecan (SKB264) plus Tislelizumab and Sacituzumab Tirumotecan (SKB264) in people with Advanced Thyroid Carcinoma and Radioiodine-refractory Differentiated Thyroid Cancer, run by Zhejiang Provincial People's Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sacituzumab Tirumotecan (SKB264) plus Tislelizumab and Sacituzumab Tirumotecan (SKB264)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteChina
Study dates
1 Jul 2025to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet all of the following criteria:
  • 1. Age ≥ 18 years at the time of informed consent. 2. Histologically confirmed unresectable, locally advanced, or metastatic:
  • 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.
  • 3. For ATC or PDTC:
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  • No BRAF V600E mutation, RET fusion, NTRK fusion, or ALK fusion;
  • Or harboring such alterations but have failed prior standard first-line targeted therapy.
  • 4. For RAIR-DTC: Disease must be refractory to radioactive iodine (RAI), defined as at least one of the following:
  • No RAI uptake in measurable lesions;
  • Radiographic progression within 12 months after RAI therapy;
  • Cumulative RAI dose >600 mCi (or iodine-equivalent);
  • Fluorodeoxyglucose (FDG)-avid measurable disease;
  • Failure of prior multi-target tyrosine kinase inhibitor (TKI) therapy. 5. At least one measurable lesion per RECIST version 1.1. 6. ECOG performance status 0-2. 7. Life expectancy ≥ 12 weeks. 8. Adequate hematologic function:
  • Absolute neutrophil count ≥ 1.2 × 10⁹/L
  • Platelet count ≥ 100 × 10⁹/L
  • Hemoglobin ≥ 90 g/L 9. Adequate hepatic function:
  • AST and ALT ≤ 2.5 × upper limit of normal (ULN)
  • ≤ 5 × ULN if liver metastases present
  • Total bilirubin ≤ 1.5 × ULN 10. Adequate renal function:
  • Creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula)
  • No active autoimmune disease requiring systemic therapy.
  • No concurrent active malignancy requiring treatment.
  • Willing and able to provide written informed consent.

Who cannot join

  • Participants meeting any of the following criteria will be excluded:
  • 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).
  • Uncontrolled or symptomatic central nervous system metastases.
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  • Patients with treated and stable CNS disease for ≥4 weeks and off corticosteroids for ≥2 weeks may be eligible.
  • Significant uncontrolled comorbidities including, but not limited to:
  • Uncontrolled hypertension
  • Severe diabetes mellitus
  • Active infection
  • History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroids, or current suspected ILD.
  • Unresolved toxicities from prior anti-cancer therapy greater than Grade 1 (CTCAE v5.0), except alopecia or other clinically insignificant toxicities.
  • Active autoimmune disease requiring systemic treatment within the past 2 years (excluding hormone replacement therapy such as levothyroxine or physiologic corticosteroids).
  • Systemic corticosteroid use >10 mg/day prednisone equivalent within 10 days prior to first dose (except inhaled, topical, or physiologic replacement doses).
  • Known HIV infection or AIDS. Active syphilis infection.
  • History of allogeneic organ transplantation or hematopoietic stem cell transplantation.
  • Known severe hypersensitivity to study drugs or components.
  • Chemotherapy, radiotherapy, immunotherapy, biologic therapy, TKI, or systemic immune stimulation within protocol-defined washout period prior to first dose.
  • Pregnant or breastfeeding women.
  • Severe ocular disorders that may interfere with corneal healing (e.g., severe dry eye syndrome, severe meibomian gland disease).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kexin Meng contact

86-571-85893567

mengkexin007@gmail.com

China1 site, 1 recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014

    Kexin Meng, MD, +86-571-8589-3567, mengkexin007@gmail.com

    Recruiting

Other trials in China

About this study

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

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.

Being tested
Sacituzumab Tirumotecan (SKB264) plus Tislelizumab, Sacituzumab Tirumotecan (SKB264)
Keywords
radioiodine-refractory differentiated thyroid cancer, Sacituzumab tirumotecan, immunotherapy, TROP2, anaplastic thyroid carcinoma, Poorly Differentiated Thyroid Carcinoma, Tislelizumab
Medical subject headings
Thyroid Carcinoma, Anaplastic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab Tirumotecan (SKB264) plus TislelizumabDrug

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

  • Sacituzumab Tirumotecan (SKB264)Drug

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

Study groups in NCT07068542
Study groupRoleWhat they receive
cohort AExperimentalUnresectable, locally advanced or metastatic advanced anaplastic thyroid carcinoma thyroid carcinoma (ATC)
Receives: Drug: Sacituzumab Tirumotecan (SKB264) plus Tislelizumab
cohort BExperimentalUnresectable, locally advanced or metastatic radioiodine-refractory differentiated thyroid carcinoma (RAIR-DTC)
Receives: Drug: Sacituzumab Tirumotecan (SKB264)
cohort CExperimentalUnresectable, locally advanced or metastatic advanced poorly differentiated thyroid carcinoma (PDTC)
Receives: Drug: Sacituzumab Tirumotecan (SKB264)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: From first dose until death from any cause (up to approximately 24 months after enrollment)

  2. 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.

    Measured: From first dose until documented disease progression or death (up to approximately 24 months)

Secondary outcomes (6)

  1. 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).

    Measured: From first dose until documented disease progression or death (up to approximately 24 months)

  2. 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.

    Measured: From first dose until death from any cause (up to approximately 24 months)

  3. 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.

    Measured: Up to approximately 24 months

  4. 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.

    Measured: Up to approximately 24 months

  5. Duration of Response (DoR)

    Duration of response is defined as the time from first documented objective response (CR or PR) until radiographic disease progression or death from any cause, whichever occurs first.

    Measured: Up to approximately 24 months

  6. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Incidence, severity, and relationship of treatment-emergent adverse events graded according to NCI CTCAE version 5.0.

    Measured: From first dose until 30 days after last dose (SAEs up to 90 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2025
  2. Study start1 Jul 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
94 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07068542
Sponsor's protocol ID
KY2025070
Status last verified
May 2026
First submitted
14 May 2025
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Sacituzumab Tirumotecan (SKB264) plus Tislelizumab and Sacituzumab Tirumotecan (SKB264) in people with Advanced Thyroid Carcinoma and Radioiodine-refractory Differentiated Thyroid Cancer, run by Zhejiang Provincial People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kexin Meng (86-571-85893567, mengkexin007@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) - ATC Cohort (time frame: From first dose until death from any cause (up to approximately 24 months after enrollment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07068542.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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