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RecruitingNCT07068542Updated Jun 1, 2026

Sacituzumab Tirumotecan Combined With Immunotherapy in Advanced Thyroid Cancer

An interventional study of Sacituzumab Tirumotecan (SKB264) plus Tislelizumab and Sacituzumab Tirumotecan (SKB264) in Advanced Thyroid Carcinoma, Radioiodine-refractory Differentiated Thyroid Cancer and Poorly Differentiated Thyroid Carcinoma, sponsored by Zhejiang Provincial People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by Zhejiang Provincial People's Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
94
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Thyroid Carcinoma
  • Radioiodine-refractory Differentiated Thyroid Cancer
  • Poorly Differentiated Thyroid Carcinoma

Keywords

  • radioiodine-refractory differentiated thyroid cancer
  • Sacituzumab tirumotecan
  • immunotherapy
  • TROP2
  • anaplastic thyroid carcinoma
  • Poorly Differentiated Thyroid Carcinoma
  • Tislelizumab
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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:

  • 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)

    1. No active autoimmune disease requiring systemic therapy.
    2. No concurrent active malignancy requiring treatment.
    3. Willing and able to provide written informed consent.

Exclusion criteria

Exclusion Criteria

Participants meeting any of the following criteria will be excluded:

  1. Prior therapy targeting TROP2.
  2. Prior treatment with any topoisomerase I inhibitor antibody-drug conjugate.
  3. Prior immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40) or immune cell therapy.
  4. 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).

  5. Uncontrolled or symptomatic central nervous system metastases.

    • Patients with treated and stable CNS disease for ≥4 weeks and off corticosteroids for ≥2 weeks may be eligible.

  6. Significant uncontrolled comorbidities including, but not limited to:

    • Uncontrolled hypertension
    • Severe diabetes mellitus
    • Active infection
  7. History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroids, or current suspected ILD.
  8. Unresolved toxicities from prior anti-cancer therapy greater than Grade 1 (CTCAE v5.0), except alopecia or other clinically insignificant toxicities.
  9. Active autoimmune disease requiring systemic treatment within the past 2 years (excluding hormone replacement therapy such as levothyroxine or physiologic corticosteroids).
  10. Systemic corticosteroid use >10 mg/day prednisone equivalent within 10 days prior to first dose (except inhaled, topical, or physiologic replacement doses).
  11. Known HIV infection or AIDS. Active syphilis infection.
  12. History of allogeneic organ transplantation or hematopoietic stem cell transplantation.
  13. Known severe hypersensitivity to study drugs or components.
  14. Chemotherapy, radiotherapy, immunotherapy, biologic therapy, TKI, or systemic immune stimulation within protocol-defined washout period prior to first dose.
  15. Pregnant or breastfeeding women.
  16. Severe ocular disorders that may interfere with corneal healing (e.g., severe dry eye syndrome, severe meibomian gland disease).
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
94 participants (estimated)

Study arms

  • Experimental
    cohort A

    Unresectable, locally advanced or metastatic advanced anaplastic thyroid carcinoma thyroid carcinoma (ATC)

    Drug: Sacituzumab Tirumotecan (SKB264) plus Tislelizumab

  • Experimental
    cohort B

    Unresectable, locally advanced or metastatic radioiodine-refractory differentiated thyroid carcinoma (RAIR-DTC)

    Drug: Sacituzumab Tirumotecan (SKB264)

  • Experimental
    cohort C

    Unresectable, locally advanced or metastatic advanced poorly differentiated thyroid carcinoma (PDTC)

    Drug: Sacituzumab Tirumotecan (SKB264)

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

05

What researchers measure

Primary outcomes

  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).

    Time frame: 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.

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

Secondary outcomes

  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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

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

06

Study locations

1 of 1 sites recruiting
  • Zhejiang Provincial People's Hospital
    Hangzhou, Zhejiang 310014, China
    Recruiting
07

References and documents

Study documents

  • Study protocol · Dec 1, 2025
  • Statistical analysis plan · Dec 1, 2025
  • Informed consent form · Dec 1, 2025

Documents are hosted by the registry — open the source record to download them.

08

Registry details

Key details

Study ID
NCT07068542
Lead sponsor
Zhejiang Provincial People's Hospital
Responsible party
Minghua Ge (Professor, Zhejiang Provincial People's Hospital) — Principal investigator
First posted
Jul 16, 2025
Start date
Jul 1, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jun 1, 2026

Study contacts

Kexin Meng
Contact
mengkexin007@gmail.com
86-571-85893567
Minghua Ge
principal investigator · Zhejiang Provincial People's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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