Sacituzumab Tirumotecan Combined With Immunotherapy in Advanced Thyroid Cancer

NCT07068542 | Recruiting

• 1 other identifier: KY2025070
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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).

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

• 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.

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

Secondary Outcomes (6)

• Progression-Free Survival (PFS) - ATC Cohort

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

• Overall Survival (OS) - PDTC and RAIR-DTC Cohorts

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

• Objective Response Rate (ORR)

  Up to approximately 24 months

• Disease Control Rate (DCR)

  Up to approximately 24 months

• Duration of Response (DoR)

  Up to approximately 24 months

Study Arms (3)

cohort A

EXPERIMENTAL

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

Drug: Sacituzumab Tirumotecan (SKB264) plus Tislelizumab

cohort B

EXPERIMENTAL

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

Drug: Sacituzumab Tirumotecan (SKB264)

cohort C

EXPERIMENTAL

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

Drug: Sacituzumab Tirumotecan (SKB264)

Interventions

Sacituzumab Tirumotecan (SKB264) plus Tislelizumab DRUG

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

cohort A

Sacituzumab Tirumotecan (SKB264) DRUG

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

cohort B; cohort C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following criteria:
• \. 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.
• \. 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.
• \. 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

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead

Study Sites (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

RECRUITING

MeSH Terms

Conditions

Thyroid Carcinoma, Anaplastic

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Minghua Ge

  Zhejiang Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kexin Meng

CONTACT

86-571-85893567; mengkexin007@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: July 16, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 24, 2026

Record last verified: 2025-05

Locations

CN (1)