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Sacituzumab Tirumotecan Combined With Immunotherapy in Advanced Thyroid Cancer

NCT07068542 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2026-02-24

No results posted yet for this 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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Zhejiang Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Minghua Ge · Zhejiang Provincial People's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07068542 on ClinicalTrials.gov