RecruitingPhase 2NCT06235216

Sacituzumab govitEcan in THYroid Cancers

A Multicenter, Open Label, Two Cohort, Single Arm, Phase II Study to Evaluate the Efficacy and Safety of the Anti-TROP2 Antibody-drug Conjugate Sacituzumab Govitecan in Patients With Advanced Differentiated and Anaplastic Thyroid Neoplasms.


Sponsor

Grupo Espanol de Tumores Neuroendocrinos

Enrollment

42 participants

Start Date

Sep 13, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

SETHY is a prospective, multicohort, phase II, single-arm, non-randomized, non-blinded, investigator-initiated study of sacituzumab govitecan in patients with advanced or metastatic radioactive-iodine refractory differentiated thyroid carcinoma (DTC) or anaplastic thyroid carcinoma (ATC). The main hypothesis is that treatment with sacituzumab govitecan, a anti-Trophoblast cell surface antigen 2 (TROP-2), could be an effective treatment option for patients with either differentiated and anaplastic thyroid neoplasms because TROP-2 is highly expressed at the membrane of DTC and ATC.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing sacituzumab govitecan — an antibody-drug conjugate that delivers chemotherapy directly to cancer cells — in patients with advanced thyroid cancer that no longer responds to standard treatments, including radioactive iodine. **You may be eligible if...** - You are 18 or older - You have advanced differentiated thyroid cancer (Cohort A) that is refractory to radioactive iodine and has progressed on 1–3 prior drug therapies; OR anaplastic thyroid carcinoma (Cohort B) in first-line or after up to 1 prior treatment - Your cancer is measurable on scans - You are in reasonably good general health (ECOG 0–1) - Your blood counts, liver, and kidneys meet the required levels **You may NOT be eligible if...** - You have had more than 3 prior drug therapies (Cohort A) or more than 1 (Cohort B) - Your blood counts, liver, or kidney values are below acceptable thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab govitecan

Dose of 10 mg/kg intravenously


Locations(11)

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Complexo Hospitalario Universitario de Ferrol

Ferrol, Spain

Institut Catala d´Oncologia (ICO) -Hospitalet

Hospitalet de Llobregat (Barcelona), Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital Universitario la Paz

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

MD Anderson Cancer Center Madrid

Madrid, Spain

Hospital General Universitario Morales Meseguer

Murcia, Spain

Hospital Universitario Central de Asturias

Oviedo, Spain

H.U. Marqués de Valdecilla

Santander, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

View Full Details on ClinicalTrials.gov

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NCT06235216


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